PLM news, announcements and industry trends.

steepgraph.com · Oct 28, 2026

PLM Software

We explore the top 10 PLM platforms recognized as industry leaders in 2026 for their robust capabilities, flexible deployment options, and AI-driven innovation. KJ Kajol Jaiswal Marketing Executive • Product lifecycle management (PLM) software has become the foundation for how organizations design, develop, and deliver products. In 2026, leading PLM platforms are evolving well beyond engineering data management, offering AI-assisted workflows, flexible SaaS deployment options, and digital thread connectivity that links engineering with manufacturing, quality, supply chain, and service. PLM vendors are innovating at a rapid pace. Siemens introduced an AI BOM agent and Microsoft 365 Copilot integration in Teamcenter 2606 , while Dassault Systèmes, PTC, Aras, and Oracle have each released new AI capabilities across their platforms this year. This guide reviews ten leading PLM platforms in 2026, outlining the core capabilities, deployment options, and recent innovations of each. The list is not a strict ranking; the right platform depends on an organization's products, processes, and enterprise application landscape. • How we evaluated the platforms We looked at each platform through the lens of a PLM implementation team, using six criteria: • Core PLM depth: BOM management, change and configuration management, document and CAD data management. • Deployment options: on-premises, private cloud, or true multi-tenant SaaS. • AI and analytics: copilots, agents, and search that work on governed product data. • Integration and openness: CAD/ECAD connectors, ERP/MES links, APIs, and data model flexibility. • Industry fit: proven templates and processes for specific sectors. • Total cost of ownership: licensing model, customization effort, and upgrade burden. • The top 10 PLM platforms in 2026 1 . Aras Innovator By Aras Rated 4.6 out of 5 4.6 on / Aras Innovator is a model-based, low-code product lifecycle management (PLM) platform used by organizations in aerospace and defense, industrial equipment, energy, automotive, and high tech to manage complex product data and processes. Aras provides comprehensive capabilities for BOM management, engineering change, configuration and variant management, requirements and systems engineering, quality management, and technical documentation. The platform is CAD-neutral, supporting integration with multiple MCAD and ECAD tools, and its open architecture connects with ERP, MES, ALM, and simulation systems to build a complete digital thread. Available on-premises or as Aras Enterprise SaaS, Aras Innovator includes upgrades as part of its subscription, even for customized environments, enabling organizations to tailor the platform to unique business processes without compromising long-term upgradeability. In 2026, Aras expanded its InnovatorEdge platform with API management, application development, and agentic AI services, and introduced an AI-powered Variant BOM Agent built with Microsoft to simplify variant management. 2 . 3DEXPERIENCE (ENOVIA) By Dassault Systèmes Rated 4.6 out of 5 4.6 on / Dassault Systèmes 3DEXPERIENCE is a unified business and innovation platform that brings design, engineering, simulation, manufacturing, and lifecycle management together on a single data model. ENOVIA, the platform's PLM backbone, delivers capabilities for product structure and BOM management, configuration and change management, program and project management, requirements traceability, and supplier collaboration. The platform connects natively with CATIA, SOLIDWORKS, SIMULIA, and DELMIA, enabling model-based systems engineering and virtual twin experiences across the entire lifecycle. Available on-premises and as SaaS on the 3DEXPERIENCE cloud, the platform supports organizations in aerospace and defense, automotive, high tech, industrial equipment, life sciences, and consumer goods. In 2026, Dassault Systèmes introduced Virtual Companions , AI-powered experts embedded in the platform. By July, AURA for program management, LEO for engineering, and MARIE for science were generally available on 3DEXPERIENCE SaaS . As CIMdata notes, many of these capabilities require cloud access , making SaaS adoption an important consideration. 3 . Teamcenter By Siemens Rated 4.5 out of 5 4.5 on / Siemens Teamcenter is a product lifecycle management (PLM) platform widely used by discrete manufacturing industries to unify multidisciplinary product data and process management. Teamcenter provides robust tools for design collaboration, engineering change and BOM management, end-to-end traceability, and workflow automation. The system supports multi-CAD integration, manufacturing process planning, digital twin visualization, supplier collaboration, and compliance management. Available both on-premises and via Teamcenter X SaaS cloud, Teamcenter enables organizations of all sizes to accelerate product development, drive process efficiency, and ensure quality across the entire lifecycle. The platform's flexible architecture integrates with ERP, MES, ALM, and other enterprise applications for true digital thread connectivity. With Teamcenter 2606 , Siemens introduced an AI BOM agent for guided change workflows, extended Teamcenter Copilot into MBSE and quality, and brought PLM context into Microsoft 365 Copilot. At Realize LIVE 2026, Siemens also launched Intelligence Center X , an industrial AI and data orchestration layer across the Siemens Xcelerator portfolio. 2 . Windchill By PTC Rated 4.4 out of 5 4.4 on / PTC Windchill is an enterprise product lifecycle management (PLM) platform that manages product data and processes from concept through service. Windchill offers robust capabilities for CAD data management, part and BOM management, engineering change and configuration management, BOM transformation, quality and regulatory compliance, and supplier collaboration. The platform provides native integration with Creo along with support for other leading MCAD and ECAD tools, and connects with Codebeamer for ALM and ServiceMax for field service to extend the digital thread. Available on-premises and as Windchill+ SaaS in the PTC cloud, Windchill delivers out-of-the-box best practices that help organizations in industrial equipment, medical devices, high tech, and automotive reduce implementation effort and accelerate time to value. In April 2026, PTC released Windchill AI Assistant , which enables users to ask questions in natural language and receive answers from Windchill documents while maintaining existing security and access controls. PTC plans to extend AI agents into parts and change management. 5 . SAP PLM (with SAP Teamcenter) By Siemens Rated 4.5 out of 5 4.5 on / SAP PLM is a set of product lifecycle management capabilities embedded in SAP S/4HANA that connects product data directly with procurement, manufacturing, supply chain, finance, and service processes. SAP PLM provides tools for product structure and BOM management, recipe and specification management, engineering change records, variant configuration, document management, and product compliance. For engineering data and multi-CAD management, SAP offers SAP Teamcenter by Siemens as part of its PLM portfolio. Supporting on-premises, cloud, and hybrid deployments, SAP PLM enables organizations, particularly in process industries and SAP-centric enterprises, to maintain a single product master across engineering and operations. The two systems are linked through Teamcenter Integration for SAP S/4HANA , a connector co-developed by Siemens and SAP that allows users to start or complete processes in either system. 6 . Oracle Fusion Cloud PLM By Oracle Rated 4.6 out of 5 4.6 on / Oracle Fusion Cloud PLM is a SaaS product lifecycle management solution that unifies innovation, product development, quality, and compliance on a single enterprise product record shared with Oracle Fusion Cloud SCM and ERP. The platform provides capabilities for idea and concept management, portfolio management, item and BOM management, engineering change, quality management including CAPA and nonconformance, product compliance, and product data hub. Built on the Redwood user experience with quarterly updates, Oracle Fusion Cloud PLM helps organizations in high tech, life sciences, industrial, and consumer goods connect product decisions directly with supply chain execution. In February 2026, Oracle introduced prebuilt AI agents for Fusion Cloud SCM at no additional cost to existing customers, including a Component Replacement Agent that helps PLM teams automate component replacement. Customers can also build custom agents using Oracle AI Agent Studio. 7 . Arena By PTC Rated 4.3 out of 5 4.3 on / Arena, part of PTC, is a cloud-native product lifecycle management (PLM) and quality management system (QMS) designed for organizations that develop products with distributed teams and outsourced supply chains. Arena provides capabilities for item and BOM management, engineering change management, document control, CAPA and nonconformance, training records, supplier collaboration, and regulatory compliance. The platform integrates with MCAD and ECAD tools, including the Onshape-Arena Connection, as well as leading ERP systems. As a true SaaS solution with no on-premises infrastructure, Arena enables rapid deployment and is widely adopted in electronics, medical devices, and high-tech hardware. The Arena 2026.2 release introduced Arena Connect for workflow automation across ERP, MES, and other enterprise systems, building on the Arena AI Assistant and Arena AI Engine. Arena was also named a Visionary in the 2026 Gartner Magic Quadrant for PLM software in discrete manufacturing industries. 8 . Autodesk Fusion Manage By Autodesk Rated 4.7 out of 5 4.7 on / Autodesk Fusion Manage is a cloud-based product lifecycle management (PLM) solution within the Autodesk Fusion industry cloud that helps organizations manage product data and processes across engineering, operations, and the supply chain. Fusion Manage provides capabilities for BOM management, change orders, new product introduction (NPI), project management, quality processes, and supplier collaboration. The platform integrates natively with Autodesk Vault, Inventor, and Fusion, and its configurable, no-code workspaces enable teams to adapt workflows quickly. As a SaaS solution with predictable subscription pricing, Fusion Manage is well suited to small and mid-sized businesses seeking fast time to value. At Autodesk University 2026, Autodesk previewed an agentic PLM experience for Fusion Manage that brings lifecycle work into an AI-driven canvas connected to email, chat, and enterprise systems. 9 . Propel By Propel Software Solutions Rated 4.5 out of 5 4.5 on / Propel is a cloud-native platform built on Salesforce that unifies product lifecycle management (PLM), quality management (QMS), and product information management (PIM). Propel provides capabilities for item and BOM management, engineering change, document control, CAPA and complaint management, supplier collaboration, and product content management for marketing and sales teams. Its DesignHub solution connects more than 15 mechanical and electrical design tools to Propel PLM. By linking engineering data with commercial and service functions, Propel helps organizations in high-tech, medical devices, and consumer goods manage the full product journey from concept to customer. Propel One, the company's agentic AI solution powered by Salesforce Agentforce, embeds AI skills across item, BOM, change, and quality processes. Propel reported record FY26 bookings , driven in part by organizations replacing end-of-life legacy PLM systems. 10 . Centric PLM By Centric Software Rated 4.0 out of 5 4.0 on / Centric PLM is a product lifecycle management solution purpose-built for fashion, footwear, retail, and consumer goods. Centric provides capabilities for line planning, product design and development, materials and specification management, sourcing and supplier collaboration, costing, quality, and compliance. Delivered as SaaS with embedded industry best practices, Centric PLM helps brands and retailers accelerate time to market and respond quickly to changing consumer demand. Part of Dassault Systèmes, Centric has expanded beyond apparel into food and beverage, cosmetics, personal care, and consumer electronics. In June 2026, Dassault Systèmes named Centric PLM its preferred solution for consumer packaged goods and retail . Centric also launched Centric AI Studio , which brings AI-powered visual content creation directly into PLM workflows. • Comparison at a glance Platform Deployment Best for Standout strength Watch out for Aras Innovator On-prem, SaaS Complex or unique processes Flexible model, upgrades included Governance of customization Dassault 3DEXPERIENCE / ENOVIA On-prem, SaaS CATIA/SOLIDWORKS users, A&D, automotive Single data model, Virtual Companions New AI is cloud-first Siemens Teamcenter On-prem, SaaS (Teamcenter X) Large multi-site enterprises Portfolio breadth, AI agents, SAP link Scope and cost PTC Windchill On-prem, SaaS (Windchill+) Industrial, medtech, Creo users Out-of-the-box BOM and change Legacy customization SAP PLM + Teamcenter On-prem, cloud, hybrid SAP-centric enterprises One product master with ERP Needs Teamcenter for CAD depth Oracle Fusion Cloud PLM SaaS only Oracle ERP/SCM customers PLM-to-supply-chain record Separate PDM for CAD Arena (PTC) SaaS only Electronics and medtech scale-ups PLM + QMS, fast setup Complex configured products Autodesk Fusion Manage SaaS only SMBs on Inventor/Vault Fast, no-code configuration Large enterprise scale Propel SaaS (Salesforce) High tech, medtech, consumer PLM + QMS + PIM Salesforce org health Centric PLM SaaS Fashion, retail, CPG Deep industry templates Not for engineering-heavy work • How to choose the right PLM platform Start with your processes and data, not the vendor demo. Gartner expects the share of companies relying on PLM as a core system for AI-driven product innovation to rise from about 20% today to over 60% by 2030 ( source ). That makes the quality of your product data foundation more important than any single AI feature. • Map your current state. Document how BOMs, changes and releases flow today, and where data is duplicated or lost. • Define must-have processes. Separate true differentiators from processes that can follow vendor best practice. • Check your CAD and ERP landscape. Native integration with your design tools and ERP often narrows the shortlist fast. • Decide on deployment. SaaS lowers upgrade effort and unlocks the newest AI features; on-premise may still suit strict data sovereignty or heavy customization needs. • Test AI on your own data. Ask vendors to demo copilots and agents against a sample of your real product data, not a curated dataset. • Plan migration early. Legacy data cleansing and migration is often the longest part of a PLM program. • Calculate total cost of ownership. Include licenses, implementation, integrations, upgrades and internal admin over five years. • Run a scripted proof of concept. Use your own use cases and score each platform against the same criteria. • Conclusion: Each platform in this list offers proven PLM capabilities, but successful outcomes depend on selecting a solution aligned with business requirements and executing a well-structured implementation. Organizations that combine the right platform with clean product data and a phased rollout realize the greatest value from their PLM investment. At SteepGraph, PLM is all we do. Our consultants help organizations assess options, plan migrations, and implement and integrate PLM so it delivers measurable value. Talk to a SteepGraph PLM expert about your 2026 PLM roadmap. What is the best PLM software in 2026? There is no single best PLM platform. Teamcenter, 3DEXPERIENCE and Windchill lead for large, engineering-heavy enterprises; Aras suits companies with unique processes; Arena, Propel and Fusion Manage suit fast-growing companies that want SaaS; Centric leads in fashion and consumer goods. What is the difference between PLM and PDM? PDM (product data management) manages CAD files and engineering data. PLM covers the whole lifecycle, including BOMs, change management, quality, compliance, manufacturing and service, and connects engineering with the rest of the business. Is cloud PLM better than on-premise PLM? Cloud PLM reduces infrastructure and upgrade effort, and many new AI capabilities are delivered SaaS-first. On-premise can still make sense for strict data sovereignty, defense programs or heavily customized systems. How long does a PLM implementation take? It depends on scope. A focused SaaS rollout for a smaller company can take a few months, while an enterprise program with data migration and ERP integration often runs in phases over a year or more. How is AI changing PLM? Vendors are adding copilots that answer questions from product data and agents that automate tasks such as BOM changes, part reuse, and compliance checks. AI is only as good as the underlying data, so clean, connected PLM data is the foundation. Can we switch PLM platforms later? Yes, but migration is costly.

jamasoftware.com · Oct 28, 2026

AI in Product Development · PLM Software

AI-assisted coding has made building internal software faster and more accessible. An engineer can now use generative AI to create a working requirements management application without the development effort that would have been necessary just a few years ago. For organizations looking to reduce software spending and improve efficiency, building an internal tool can seem like a practical alternative to adopting a dedicated requirements management system. But a working application is only the beginning. As engineering teams begin relying on homegrown requirements tools to manage product decisions, track changes, connect verification evidence, and support development across disciplines, they inherit responsibilities that may not have been part of the original plan. The central risk is whether the organization can maintain, secure, scale, and trust that tool throughout the product development lifecycle. Why More Engineering Teams Are Considering Homegrown Requirements Tools Building internal software is not a new idea. Engineering organizations have long developed custom applications to address specialized workflows, automate repetitive tasks, and work around limitations in existing systems. What’s changed is the barrier to entry. AI coding assistants allow developers to generate application code, create interfaces, connect databases, and implement functionality through natural-language instructions. The result is that an internal application that once required significant development resources can now be prototyped much more quickly. At the same time, organizations face pressure to manage technology spending while increasing engineering productivity. When a software engineer can demonstrate a functional requirements management application built with AI, the question naturally follows. Why invest in a dedicated system if we can create one ourselves? The answer depends partly on how the application will be used. The UK’s National Cyber Security Centre (NCSC) recognizes this distinction in its vibe coding guidance . Published in June 2026, the guidance recommends adjusting oversight according to the risk of the application. Prototypes and limited-exposure internal tools may justify greater autonomy, while systems handling sensitive information, authentication, or safety-critical functions require more rigorous controls. The challenge begins when an application developed for a narrow purpose becomes essential infrastructure for product development. A Working Requirements Tool Isn’t the Same as a Production-Ready System A homegrown requirements tool may initially accomplish exactly what its developer intended. Users can enter requirements, organize information, make updates, and perhaps establish basic relationships between records. The interface works, the team can access its data, and the initial project appears successful. But production use introduces an entirely different set of expectations. The application now needs to remain available, protect sensitive information, support multiple users, preserve historical records, and accommodate changes to both the product and the organization’s engineering processes. This creates additional development risks that may never have appeared in the original project estimate. The team must consider questions such as: • Who is responsible for hosting, monitoring, backups, and disaster recovery? • How will the application handle more users, projects, requirements, and product variants? • Who maintains security controls and responds to vulnerabilities? • What happens when integrations break or external systems change? • Who provides support, training, and ongoing development? These responsibilities do not disappear once the initial application is working. They continue for as long as the organization depends on the system. The NIST Secure Software Development Framework reinforces the distinction between producing functional software and maintaining a secure software development lifecycle. Its recommended practices address software protection, vulnerability management, secure development, and responding to security issues. For engineering organizations, the question is whether maintaining another production application is the best use of internal resources. The Hidden Costs, Risks, and Safety Implications of Homegrown Requirements Tools The effort required to build an interface is visible. The ongoing costs and risks of keeping a requirements management system reliable are harder to estimate. Gaps in availability, security, or governance can disrupt engineering work, compromise sensitive information, and weaken confidence in product decisions. In regulated or safety-critical development, those gaps can also have compliance and product safety implications. Infrastructure, Availability, and Scalability Once teams depend on an internal requirements tool, its availability can affect their ability to perform everyday engineering work. For example, an outage may prevent engineers from accessing approved requirements, reviewing changes, or retrieving information needed for development and testing. If the application is self-hosted, the organization must maintain the infrastructure supporting it. That includes backup schedules, recovery procedures, monitoring, redundancy, and the ability to restore service after an incident. Scalability introduces another challenge. A tool designed for a small engineering team may perform adequately with hundreds of requirements. The same architecture may behave differently when it must support thousands of linked artifacts, multiple projects, product variants, distributed teams, and years of development history. Engineering leaders need to consider how performance, data integrity, and availability will be maintained as the system grows. Security and Governance Requirements management systems frequently contain sensitive intellectual property, product specifications, proprietary designs, and information about unreleased technologies. In some industries, they may also contain regulated or sensitive personal information. An internally developed system needs appropriate authentication, authorization, encryption, logging, vulnerability management, and controls over data access. AI-generated code adds additional considerations. The OWASP Secure Coding With AI Cheat Sheet identifies risks associated with AI-assisted coding, including vulnerable dependencies, prompt injection, sensitive-context leakage, and insufficient human oversight. These risks can be managed, but doing so requires deliberate engineering practices. An application that works correctly in a demonstration has not necessarily undergone the security reviews expected of a production system. Organizations also need to determine which certifications, independent assessments, or documented controls their customers and internal policies require. SOC 2, for example, is an attestation framework for service organizations, not a universal requirement for every internal engineering application. The larger issue is ongoing accountability. Security must be maintained as code, dependencies, integrations, and threats evolve. Maintenance, Support, and Institutional Knowledge A homegrown tool may begin with one engineer who understands the application and can quickly address issues. As adoption expands, the organization becomes increasingly dependent on that individual’s knowledge. What happens when the original developer moves to another project or leaves the company? Without documented architecture, established support procedures, and shared ownership, even routine changes may become difficult. New developers must understand how the application works before they can safely modify it. Meanwhile, users still need training, support, bug fixes, and additional capabilities. Over time, the organization may effectively be maintaining another software product, even though its core business is developing something else. Traceability and Change Management Become More Complex as Products Grow Engineering teams need to understand how requirements relate to stakeholder needs, design decisions, implementation activities, risks, tests, and verification evidence. These relationships become increasingly important as product complexity grows. Consider a system requirement that changes after development has already begun. That change could affect software behavior, hardware interfaces, supplier specifications, test procedures, and previously approved risk controls. Without reliable traceability, engineers may need to investigate these relationships manually to determine which downstream activities require attention. A homegrown application might support basic links between records, but managing relationships across multiple engineering disciplines requires additional capabilities, including consistent relationship rules, coverage analysis, and change impact assessment . Requirements traceability is the ability to follow a requirement through its related development artifacts, including changes, implementation, and verification. For complex products, traceability must remain useful as requirements evolve. If relationships are maintained manually or updated inconsistently, teams may discover gaps only during integration, verification, or an audit. A team could complete testing against an outdated requirement without realizing the test no longer verifies the approved product definition. That creates the possibility of late-stage rework , delayed releases, and unresolved quality issues. Versioning, Baselines, and Decision History Must Hold Up Over Time Knowing the current state of a requirement is useful. Understanding its history is equally important. Engineering organizations need to answer questions that become more difficult as products evolve: • Which version of the requirement was approved for a particular release? • Who reviewed and approved it? • What changed after that approval? • Which tests and design artifacts were associated with the approved version? • Can the team reconstruct the requirements baseline used at an earlier milestone? A basic application may preserve the latest version of a record without capturing the full context behind its evolution. For example, a requirement may have been updated several times after a design review. If the system cannot preserve the approved baseline and associated evidence, teams may struggle to demonstrate what was actually reviewed. The same challenge applies to electronic approvals and audit trails. A record that shows when someone clicked an approval button is not necessarily sufficient to establish which content they reviewed, whether they had the appropriate authority, or whether the approved information subsequently changed. A production requirements management system needs to preserve decision history in a form that supports the organization’s engineering and quality processes. This is especially important when products have long development lifecycles, multiple variants, or formal review milestones. Integrations Add Ongoing Costs and Data Integrity Risks Requirements information rarely exists in isolation. Software teams may work in Jira or Azure DevOps. Hardware teams use specialized design tools. Verification teams maintain test systems, while suppliers exchange specifications and related data through their own platforms. A homegrown requirements tool must fit into this environment. Initially, a few custom integrations may be enough. As the system becomes more widely used, teams may need additional application programming interfaces (APIs), data synchronization, reporting capabilities, and support for exchange formats such as Requirements Interchange Format (ReqIF). Each integration introduces dependencies that must be maintained. If an external system changes its API, authentication requirements, or data structure, the internal application may need to be updated. Failed synchronization can leave different engineering teams working with inconsistent information. The growing adoption of AI agents creates further expectations. Model Context Protocol (MCP) can give AI tools access to engineering systems, but connectivity alone does not establish which requirements are approved, how artifacts relate to one another, or what actions an agent is authorized to perform. For organizations adopting AI-assisted engineering , maintaining trusted product context becomes another important consideration. The Risks of Homegrown Requirements Tools Vary by Industry The challenges of homegrown requirements management apply across industries, but the consequences can be particularly significant in regulated and safety-critical product development. Medical device and automotive engineering illustrate how industry-specific requirements introduce additional considerations for tool validation, traceability, and compliance. Medical Device Development Medical device manufacturers must maintain controlled design and development processes, including appropriate documentation, risk management, verification, and validation activities. Requirements may need to connect user needs, design inputs, design outputs, identified hazards, risk controls, and verification evidence. The U.S. Food and Drug Administration’s Quality Management System Regulation , effective February 2, 2026, incorporates ISO 13485:2016 into the medical device quality system framework. This makes the ability to maintain reliable design and development records especially important. Under ISO 13485 and FDA Computer Software Assurance (CSA) principles, any software used to automate part of the quality system or maintain design history files must be validated for its intended use. With a homegrown tool, the burden of writing validation protocols, executing test scripts, proving Part 11 compliance for electronic signatures, and re-validating after every hotfix falls entirely on your internal engineering and QA teams. While adopting an established requirements management platform doesn’t eliminate an organization’s validation responsibilities, it can reduce the effort involved by providing documented functionality, established controls, and validation resources. If the system cannot preserve the necessary relationships or evidence, teams may face additional effort reconstructing records for quality reviews, regulatory submissions, or inspections. In medical device development, inadequate requirements governance can become a product quality and patient safety concern. Automotive Development Automotive engineering organizations manage complex relationships between system requirements, software, electronics, functional safety, and cybersecurity. Standards and frameworks such as ISO 26262 , ISO/SAE 21434, and Automotive SPICE (ASPICE) establish expectations for relevant engineering activities, depending on the product and assessment scope. A homegrown tool may need to support requirements decomposition , change management, verification traceability, controlled baselines, and exchanges with suppliers. For safety-related development, teams may also need to assess the confidence required in their software tools and whether qualification measures are necessary. The challenge increases when requirements span multiple vehicle platforms, software releases, and supplier organizations. Build vs. Buy Should Account for the Full Product Lifecycle The traditional build-vs.-buy discussion often begins with implementation effort. How quickly can the organization develop an application? How much engineering work will the initial version require? Can an internal team create the capabilities users need? AI has changed the answers to some of those questions, but engineering leaders should evaluate the entire lifecycle rather than the initial build. Evaluation Area Questions to Consider Infrastructure Who owns hosting, monitoring, availability, backups, and disaster recovery? Security Who maintains access controls, performs security reviews, and responds to vulnerabilities? Requirements Governance Can the system preserve baselines, reviews, approvals, and historical decisions? Traceability Can teams identify missing relationships and assess downstream change impacts? Validation and change control Who assesses intended use, maintains assurance evidence, and evaluates changes to the application, model, prompts, and integrations? Integrations Who builds, monitors, and maintains connections with other engineering tools? Scalability Will the architecture support more requirements, users, variants, and projects? Support Who trains users, resolves issues, and maintains documentation? Continuity Can the organization maintain the application if its original developers leave? A custom application may still be the right choice for a particular organization, but the decision should account for the engineering effort required to maintain the system throughout its useful life. The total cost of ownership of a homegrown requirements tool includes the ongoing work required to operate, secure, maintain, integrate, and govern it, not only the effort needed to build the initial application. That distinction matters when the people responsible for maintaining the tool are also responsible for delivering the organization’s products. Use AI to Accelerate Engineering Without Sacrificing Governance The risks of homegrown requirements tools do not diminish the value of AI-assisted engineering. AI can help teams analyze requirement quality, identify ambiguity, generate test cases, investigate changes, and reduce repetitive engineering work. The opportunity is to apply AI where it improves engineering productivity while maintaining control over the information and decisions that guide development. For example, an AI agent might help identify requirements affected by a design change, but the quality of its analysis depends on access to accurate requirements, established relationships, approved versions, and relevant product context . Without that information, the agent may produce a plausible response that does not reflect the actual state of the product. A governed requirements management system provides a foundation for using AI against controlled engineering information. Rather than recreating the infrastructure for managing requirements, organizations can focus AI-assisted development on the engineering activities that contribute directly to product delivery. How Jama Connect Supports Governed Requirements Management Jama Connect® provides a purpose-built requirements management system for organizations developing complex, multidisciplinary products. Its Live Traceability™ capabilities connect requirements with related development artifacts, risks, tests, and verification evidence. Teams can maintain baselines, conduct structured reviews, document approvals, and assess the impact of changes across the development lifecycle. Jama Connect also supports integration with other engineering tools, allowing teams to continue working within established development environments while maintaining a controlled requirements record. For organizations adopting AI-assisted engineering, Jama Intelligence provides governed AI capabilities within the platform while Jama Connect MCP connects external AI tools to trusted product context. Together, they support workflows such as requirements analysis, change impact assessment, and test case generation while maintaining permissions, traceability, and audit controls. This allows teams to accelerate engineering work without requiring organizations to build and maintain every supporting system themselves. When Requirements Become Critical Infrastructure, Trust Matters Homegrown requirements tools can solve real problems, but organizations become responsible for much more over time, including infrastructure, security, integrations, maintenance, support, and governance. AI has made internal software faster to create, but it has not eliminated these responsibilities. Before committing to a homegrown requirements management system, engineering leaders should consider whether maintaining that system is the best use of their teams’ time and expertise. See how Jama Connect provides a controlled, traceable, and scalable foundation for complex product development. Explore Jama Connect, or get a personalized demo to see for yourself. Get a Demo Author Recent Posts Steven Pink I’m a creative thinker with a passion for technology. I use my skills in requirements gathering, process improvement, prototyping, and project management to innovate and leverage technology to achieve measurable ROI.

jamasoftware.com · Oct 28, 2026

Standards & Regulation

The scope block of a design and development procedure written before 2026 usually cites 21 CFR 820.30, a section of the U.S. Code of Federal Regulations (CFR) that has read “\[Reserved\]” since 2 February 2026. The work that procedure governs still has to happen under 21 CFR Part 820, which now takes its design and development requirements from International Organization for Standardization (ISO) 13485 Clause 7.3. When the Quality Management System Regulation (QMSR) took effect, the U.S. Food and Drug Administration (FDA) incorporated that standard by reference. The QMSR transition is mostly a citation job for quality and regulatory leads. Stale citations reach well past the procedure, into traceability matrix column headers and the quality system paragraph of a 510(k). A few requirements changed in substance, and a straight re-citation misses exactly those. This guide covers where each former paragraph now sits, which documents to update and what investigators look at under FDA’s new compliance program. Does 21 CFR Part 820 Still Apply After the QMSR? Yes: Part 820 is still the regulation FDA inspects device manufacturers against, including foreign manufacturers whose devices are imported into the United States. Its contents changed on 2 February 2026 under the final rule at 89 Federal Register 7496, published on 2 February 2024, which renamed it the QMSR and rebuilt it around ISO 13485:2016. Section 820.7 incorporates that standard by reference together with Clause 3 of ISO 9000:2015. Incorporated material has the force and effect of law, which means a Clause 7.3 requirement binds every manufacturer that § 820.10(c) brings into scope directly through the CFR. Only six sections remain in force, and they are the only Part 820 section numbers a current procedure should cite: • § 820.1 scope: Sets out which device manufacturers Part 820 applies to, so it is the citation for a procedure’s applicability statement. • § 820.3 definitions: Holds the definitions that apply across Part 820, including the FDA-only terms that ISO 13485 does not define. • § 820.7 incorporation by reference: Brings ISO 13485:2016 and Clause 3 of ISO 9000:2015 into the regulation by reference. • § 820.10 requirements for a quality management system: Sets the quality management system requirements, including the design and development requirement in paragraph (c). • § 820.35 control of records (Subpart B): Keeps FDA’s own record controls, including the content FDA requires in complaint records. • § 820.45 device labeling and packaging controls (Subpart B): Keeps FDA’s own controls for device labeling and packaging, also in Subpart B. When we find any other Part 820 section number in a current procedure, it’s a legacy citation that needs a new authority. For design and development work, the new authority is § 820.10(c). What Happened to the Former Design-Control Sections? Most of the old regulation is Reserved, including the design-control sections of the 1996 Quality System (QS) regulation. The Reserved block covers § 820.5, §§ 820.20 through 820.30, § 820.40 and Subparts C through O. Section 820.30 was titled “Design Controls”, and the 1997 Design Control Guidance for Medical Device Manufacturers that explained it was withdrawn on the same day the QMSR took effect. The design and development obligation now arrives through the QMSR requirement in § 820.10(c). Its text reads, “Manufacturers of class II, class III, and those class I devices listed in paragraph (c)(1) of this section and table 1 to paragraph (c)(2) of this section must comply with the requirements in Design and Development, Clause 7.3 and its Subclauses in ISO 13485.” The sentence does the scoping job that § 820.30(a) of the QS regulation used to do, in the standard’s vocabulary. The QMSR does not use the terms “Design Controls” or “Design Validation”, and FDA’s guidance notices say the elements behind them are described in ISO 13485 Clause 7.3 and its subclauses. FDA’s final rule also eliminated “Design History File (DHF)” along with the other record types of the 1996 QS regulation. The guide to ISO 13485 covers the standard itself and the retained Part 820 sections that sit beside it. Mapping the Former 21 CFR 820.30 Paragraph by Paragraph FDA has published no paragraph-by-paragraph crosswalk for the old design-control section. Its own texts still name a specific ISO 13485 subclause for nine of the ten former paragraphs, and (a) became the scope provision in § 820.10(c). For transfer and changes, the subclause numbers come from the Center for Devices and Radiological Health (CDRH) Learn training module on QMSR design and development, presented by Joseph Tartal, acting director of CDRH’s Division of Industry and Consumer Education. Each row of the table pairs a former paragraph with the clause that now carries it and with what FDA’s own material adds. | Former § 820.30 paragraph (now Reserved) | Subject | Where FDA places it under the QMSR | What FDA’s material adds | | (a) | General | 21 CFR 820.10(c), invoking ISO 13485 Clause 7.3 | Scope now set by § 820.10(c); most Class I devices stay outside it | | (b) | Design and development planning | Clause 7.3.2; plan record in the 7.3.10 file | FDA’s quality management system (QMS) information draft guidance and cybersecurity guidance cite 7.3.2 for the plan; the final rule preamble (Comment 31) puts the plan in the 7.3.10 file | | (c) | Design input | Clause 7.3.3 | FDA’s February 2026 cybersecurity guidance cites 7.3.3 for inputs; the proposed-rule preamble notes risk management is integrated across ISO 13485 | | (d) | Design output | Clause 7.3.4 | FDA’s February 2026 cybersecurity guidance cites 7.3.4 for outputs | | (e) | Design review | Clause 7.3.5 | Independent reviewer requirement not carried forward | | (f) | Design verification | Clause 7.3.6 | FDA’s February 2026 cybersecurity guidance cites 7.3.6 for verification | | (g) | Design validation | Clause 7.3.7; risk management spread across ISO 13485 | “Design Validation” no longer a QMSR term | | (h) | Design transfer | Clause 7.3.8 | FDA’s CDRH Learn module on QMSR design and development names 7.3.8 for transfer | | (i) | Design changes | Clause 7.3.9 | The CDRH Learn module names Clause 7.3.9 for control of design and development changes. Production changes may also implicate applicable Clause 7.5 requirements, and the medical device file under Clause 4.2.3 may need to reflect updated production specifications | | (j) | Design History File (DHF) | Clause 7.3.10 design and development file | “DHF” no longer a QMSR term | How to Read the Paragraph Mapping Each subclause in the table is cited as the standard’s own, and FDA is cited only where FDA has spoken. We’d write a comparative analysis of pre-QMSR documents the same way, and FDA’s frequently asked questions (FAQ) page on the QMSR suggests that kind of analysis. ISO 13485 numbers the Clause 7.3 subclauses 7.3.1 through 7.3.10, and their subjects broadly follow the order of the old paragraphs (a) through (j). A citation to 7.3.2 for planning or 7.3.6 for verification follows the standard’s own structure. Design review is the row in this mapping where we’d expect a procedure to need more than a new citation, because the content changed along with the numbering. Section 820.30(e) of the QS regulation required a reviewer “who does not have direct responsibility for the design stage being reviewed”, and the final rule preamble (response to Comment 46) confirms that requirement is not in the QMSR. Clause 7.3.5 requires, in FDA’s summary, that design and development review “include representatives of functions concerned with the stage under review as well as other specialist personnel.” If your design and development review procedure still mandates an independent reviewer, it asks for more than the QMSR’s text does. Nothing in Clause 7.3.5 stops a manufacturer keeping that reviewer as a stated company requirement. A procedure that still cites § 820.30(e) of the QS regulation as its authority is citing a Reserved section either way. Its review rules need a current basis in Clause 7.3.5 or in that company requirement. Read the White Paper Update Procedures and Templates That Still Cite Removed Sections Each document that governs work after 2 February 2026 should name its current authority and use current terminology, while records created before that date stay as created. A citation log with one row per document can pair each stale citation with its replacement authority and note any terminology or workflow change it forces. The general design and development procedure comes first, and teams can “re-index procedures to consolidate design planning, inputs, outputs, review, and change records under Clause 7.3.10,” as an AAMI News guest article from the Association for the Advancement of Medical Instrumentation recommends. Once the procedure is re-indexed, the procedure index and the file index template both point at 7.3.10 for what the file must contain or reference. Design and development review templates need two edits. The old § 820.30(e) citation becomes Clause 7.3.5, and the participant list records whatever the review procedure decided about the independent reviewer. Procedures outside design, such as records and complaint handling, cite removed sections too. The general record requirements formerly numbered 820.180 and the complaint-file requirements formerly numbered 820.198 remain in effect, as CDRH explained in its December 2025 QMSR webinar. Section 820.35 and ISO 13485 Clauses 4.2.5 and 8.2.2 now carry them. A complaint procedure should cite Clause 8.2.2 plus § 820.35(a), which adds FDA’s own record content for complaints involving possible failure to meet specifications. Revise Trace Matrices If your trace matrix was built under the QS regulation’s § 820.30, its column headers probably carry the old paragraph letters. Design inputs sit under (c), outputs under (d), verification under (f) and validation under (g), and under Clause 7.3 the chain survives while the headers change to the subclause numbers. One column is new, because Clause 7.3.3 requires design inputs to include applicable outputs of risk management, which the QS regulation’s § 820.30(c) did not state as explicitly. The QS regulation “explicitly addresses risk management activities only in the risk analysis requirement within design validation in Sec. 820.30(g); whereas, risk management is more broadly integrated in ISO 13485,” the 2022 proposed-rule preamble explained. Risk management belongs in the trace matrix by linking applicable risk controls to the design inputs that implement them. Reviewers can then check the Clause 7.3.3 input requirement on its face, and a Traceability Information Model can declare that link as required coverage. A matrix that treats risk as a validation-stage activity reflects how § 820.30(g) of the QS regulation was structured, while an investigator working from the QMSR may look for the input-side link. In early QMSR inspections, the top Form 483 observations “include risk management, outsourcing and purchasing, and complaint handling and feedback,” according to a 14 May 2026 Regulatory Affairs Professionals Society report of remarks by Keisha Thomas, associate director of FDA’s CDRH Office of Product Evaluation and Quality. Align Submission Text With FDA Guidance Submission text should cite ISO 13485 subclauses the way FDA’s revised cybersecurity guidance does, because FDA has updated its own guidance unevenly. The June 2023 device software functions premarket guidance still says in its body, citing the now-Reserved section, that software documentation follows “21 CFR 820.30 Subpart C – Design Controls of the Quality System Regulation”. A later FDA disclaimer sits on top of it: “This guidance document was issued prior to the effective date of the final rule. FDA encourages manufacturers to review the current QMSR to ensure compliance with the relevant regulatory requirements.” FDA revised the February 2026 cybersecurity premarket guidance for the QMSR, and its body cites ISO 13485 subclauses including 7.3.2, 7.3.3, 7.3.4, 7.3.6, 7.3.7 and 8.5, with no reference to 820.30. FDA’s October 2025 QMS-information draft guidance for premarket approval (PMA) and humanitarian device exemption (HDE) submissions sets out the vocabulary for each regulation: “When referring to 21 CFR part 820 as amended, effective on February 2, 2026, FDA uses the term ‘QMSR.’ When referring to the regulation at 21 CFR part 820 in effect before February 2, 2026, FDA uses the term ‘QS regulation.’” A 510(k) that describes design activities “per 21 CFR 820.30” is describing them under the QS regulation. Where Does the DHF Fit Under 21 CFR Part 820 Now? “DHF” remains industry usage for records now governed by Clause 7.3.10, which calls them the design and development file. The QMSR addresses what the DHF, Device Master Record (DMR) and Device History Record (DHR) held under the QS regulation through other requirements, and the guide to DHF, DMR and DHR under the QMSR sets out what changed. Section 820.3 no longer defines the three records, and the QMSR has no standalone requirement for them. “Many of the requirements previously in the DHR are largely required to be in the medical device or batch record, as described in Clause 7.5.1. Similarly, consistent with the former DHF, Clause 7.3.10 requires the design and development file to contain or reference all the records necessary to establish compliance with design and development requirements, including the design and development plan and design and development procedures,” FDA’s response to Comment 31 in the final rule preamble explains. Many of the elements the DMR held are now addressed through ISO 13485 requirements, including the medical device file under Clause 4.2.3, and § 820.3(b)’s definition of “rework” already uses “medical device file (MDF)” as its reference point. Records created before 2 February 2026 need not be revised or recreated, including to remove 1996 QS regulation terms such as design history file or device master record. Karen Masley-Joseph, senior advisor in the Office of Medical Device and Radiological Health Inspectorate within FDA’s Office of Inspections and Investigations, gave that answer at FDA’s April 2026 town hall on risk-based inspections. She added that FDA does “expect manufacturers to identify where processes might need to change to comply with the QMSR and then develop a plan that addresses any necessary changes.” Work done after the effective date has to follow current procedures and templates. The final rule amended Parts 4 and 820 and did not amend 21 CFR Part 11, which still governs the electronic records and signatures used to satisfy Part 820, an FDA predicate rule. Entries in a design and development file and an electronic trace matrix are examples of those electronic records. Part 11 controls need to stay in place while the Part 820 citations change. What Do Investigators Focus On Under Compliance Program (CP) 7382.850? CP 7382.850 itself organizes an inspection around six QMS areas, including Design and Development and engineering Change Control processes, plus four other applicable FDA requirements. On 2 February 2026 FDA withdrew the Quality System Inspection Technique (QSIT) and retired CP 7382.845 and CP 7383.001, and the updated compliance program CP 7382.850, Inspection of Medical Device Manufacturers, replaced all three. Every inspection on or after 2 February 2026 is conducted to the QMSR, including compliance follow-ups, FDA said at its April 2026 town hall. Inspection preparation should therefore follow the six areas in CP 7382.850. Investigators may review records created before the effective date to determine QMSR compliance, and a comparative analysis showing pre-QMSR documents meet QMSR requirements may be useful, according to FDA’s QMSR FAQ. Management review, quality audit and supplier audit reports are no longer exempt from inspection, the same FAQ confirms. Design history files (in the industry sense) and traceability are inspection focal points, Medical Device and Diagnostic Industry (MD+DI) reported in February 2026. A team ready for inspection can hand over the design and development file with its trace matrix and risk records on the day the investigator asks. When design inputs, outputs, verification records and risk items live in separate documents, producing the file means rebuilding the links between them by hand. Jama Connect® is a web-based requirements management and traceability platform for complex, regulated product development, and it holds those links between the items themselves. Convergent Dental reports that with Jama Connect its audit preparation decreased from three weeks to one day. Describing what the export replaced, Convergent Dental’s Electrical Systems Engineer said: “The fact that I can simply export a PDF for audit preparation saves me three weeks of time. Regulatory bodies don’t need to know that Jama Software exists because it’s exporting the same report that I had to do manually in the past, just instantly.” Convergent Dental’s figure measures audit preparation, and the same linked records serve an FDA inspection under Change Control, one of the six QMS areas in CP 7382.850. A design change that stays linked to every item it affected already holds the impact assessment an investigator may ask to see. How Jama Connect Supports Design and Development Under 21 CFR Part 820 Jama Connect’s pre-built framework for medical devices is aligned to ISO 13485, International Electrotechnical Commission (IEC) 62304, ISO 14971 and the design and development requirements of 21 CFR 820.10(c). The framework includes workflows for design inputs and design outputs. Its risk management framework ties risk records from failure mode and effects analysis (FMEA) and hazard analysis directly to design inputs and verification. When an engineer edits a design input, every verification record traced to it is flagged as suspect, and Jama Connect keeps an auditable record of how each flag was resolved. Controlled procedures and templates usually stay in the document control system, while Jama Connect holds the design and development records they govern. Export templates generate DHF and risk management file exports from selected project data, which is how the design and development file that Clause 7.3.10 describes gets assembled as an export or report. The same configurable Word and Excel templates support regulatory submission documentation, and Jama Connect Review Center‘s electronic signatures and audit trail support customers’ 21 CFR Part 11 compliance processes for the records in that file. Bringing Design Records Current Under 21 CFR Part 820 Current procedure citations should include the edition year so a future ISO edition does not appear adopted before FDA amends the rule. Section 820.7 incorporates ISO 13485:2016 in its third edition, dated 2016-03-01. On later editions, the final rule states that “Any future revisions to these standards would need to be evaluated to determine the impact of the changes and whether this rule should be amended.” The regulation’s core requirements, and the steps to prepare for an inspection under it, are covered in Jama Software®’s guide to the QMSR. A first pass lists every design and development record that still cites the Reserved 820.30 and pairs each citation with its Clause 7.3 subclause. If that list is long, take the product with the nearest scheduled design change first, and map its design and development file to the new subclause numbers when you start a free 30-day trial. Read the QMSR Guide Start Your Free Trial Frequently Asked Questions About 21 CFR Part 820 Does FDA require ISO 13485 certification under the QMSR? No. FDA incorporated the standard’s requirements into 21 CFR Part 820 by reference, and it will neither require nor issue a certificate of conformance to ISO 13485. A certificate does not exempt a manufacturer from FDA inspection either. The four other applicable FDA requirements in CP 7382.850, Medical Device Reporting among them, also sit outside what a certificate covers. Which Class I devices must meet the design and development requirements? Section 820.10(c)(1) applies Clause 7.3 to Class I devices automated with computer software. Table 1 to § 820.10(c)(2) adds five listed devices: the tracheobronchial suction catheter, the non-powdered surgeon’s glove, the protective restraint, the manual radionuclide applicator system and the radionuclide teletherapy source. Other Class I devices remain outside Clause 7.3, and the guide to medical device requirements management covers how in-scope devices carry user needs into design inputs. Do ISO 13485 definitions override FDA’s own definitions in Part 820? The order runs the other way. Section 820.3(b) states that definitions in section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) “shall supersede” the correlating ISO 13485 terms, so “device” and “labeling” carry their FD&C Act meanings and “organization” in the standard is read as “manufacturer.” Section 820.3(a) then adds FDA-only terms such as “component” and “remanufacturer” that neither ISO 13485 nor ISO 9000 defines.

durolabs.co · Oct 28, 2026

CAD, CAE & Simulation · PLM Software

Duro Design is an AI-native, API-first platform built for modern hardware development. Product Data Management (PDM) Duro Drive protects your work from overwrites without leaving your CAD tool. Coming Soon Integrations Flexibility to build the hardware tech stack your team deserves. API Duro’s GraphQL API allows you to query rich data on your libraries. Solutions Close Solutions Open Solutions SOLUTIONS BY INDUSTRY Aerospace & Defense Stay compliant and launch on schedule. Industrial Automation Get affordable PLM and stay agile. Computer Infrastructure Scale your computer hardware manufacturing. Energy Management Gain efficiency by centralizing documentation. Plans Resources Close Resources Open Resources Resources Resource Center Stay up to date with Duro’s latest content, including blogs, videos, eBooks and more. Read the latest articles on PLM, space tech, hardware trends and more. Success Stories See case studies on how Duro customers have achieved real results. Free Change Order Template Download our editable Change Order template PDF, completely free to use. Free BOM Template Download our editable BOM template PDF, created with our best practices. Glossary of Terms Learn common terms in the PLM and Engineering industry. Support Documentation Our full library of help articles and other support documentation. Company Close Company Open Company COMPANY About Us Get to know Duro and our mission to revolutionize hardware. Careers See our latest job listings and what makes our team tick. Press News on Duro, including fundraising, team additions and integration partnerships. Contact Us Sign In Book a Demo How to Be Better at CAD Management A Practical Guide for Growing Hardware Teams Robert Woo October 27, 2026 TABLE OF CONTENTS Key Takeaways • Good CAD management keeps designs, BOMs, revisions, and manufacturing files aligned. Organizing files is one part of making sure everyone knows what is approved and what to build. • Spreadsheets become harder to maintain as products and teams grow. Repeated data entry, conflicting revisions, and approvals buried in email are signs your process needs more structure. • Start with a few consistent rules. Standardize part numbers, define essential metadata, assign ownership, and distinguish work in progress from released designs. • Connect CAD to the broader product lifecycle. Duro’s PLM and CAD integrations help teams manage product information, publish engineering releases, and coordinate changes across departments. • Improve one workflow before expanding. Start with an active product, establish a reliable release process, and use what you learn to guide the rollout. When your hardware startup has two engineers, one prototype, and a broken foosball table, CAD management can feel straightforward. You save files in a shared folder, track parts in a spreadsheet, and ask the person sitting literally right next to you why none of this is correct. Then the company (hopefully) grows. Now you’ve got your senior mechanical engineer changing the enclosure. Your remote electrical engineer moves a connector. You’re ordering parts from last week’s BOM because the shared spreadsheet was still open on someone else’s laptop and not synced yet. And your contract manufacturer is asking which of the seven drawing revisions to use, and answering requires checking three folders and a Slack conversation. The tools that helped you get started now require constant reconciliation. It’s time for a better system that is robust enough for your growing team, but not much more complicated than Excel. Better CAD management gives your team a reliable way to organize designs, control changes, and communicate approved information. For startups that are growing, the goal is to introduce enough structure to prevent avoidable mistakes while keeping engineering moving at the pace you want. Here’s how to get there. 1. Understand What You Need to Manage CAD management includes the processes your team uses to organize, protect, review, and share design data. That covers native CAD files, assemblies, drawings, component information, revisions, and the outputs needed to manufacture a product. Several tools contribute to this process: Tool Primary role CAD: Computer-aided design Creates and modifies the engineering design. PDM: Product data management Controls design files, their relationships, and work in progress. PLM: Product lifecycle management Connects product information with BOMs, releases, approvals, sourcing, and engineering changes. The boundaries vary by platform. Some CAD systems include substantial data and release management functionality. For a growing team, the useful question is: Where does each type of information belong, and how does it reach the people who need it? Your engineers may manage active design work in CAD and PDM, then publish approved revisions and associated information into PLM. Duro’s CAD integrations support that connection, bringing engineering releases into a system accessible to the broader organization. 2. Recognize When Your Spreadsheet Is Becoming a Bottleneck Spreadsheets are familiar, flexible, easy to start using, and basically free (probably the number one reason to use them, if we’re being honest). They can be useful for early planning and basic tracking. The difficulty comes when a spreadsheet becomes the manual connection between several changing systems. An engineer updates a CAD model, then edits the drawing, exports a file, updates the BOM spreadsheet, and tells purchasing what changed. Every step depends on someone remembering to complete it. Watch for these signs that you’re outgrowing Excel : • People regularly ask which revision is approved. • CAD properties and spreadsheet BOMs disagree. • Different spreadsheets contain different descriptions for the same part. • Part numbers are assigned manually and occasionally duplicated. • Approvals are scattered across email and chat. • Preparing a supplier package involves hunting through folders. • One engineer is the only person who knows where everything lives. You don’t need to reach a particular headcount before addressing these problems. If your team spends substantial time reconciling information, the process already deserves attention. Here’s an exercise to see how this is working, or not working, for your team: start by mapping just one recent release. List every place someone entered, copied, checked, or shared information. This will reveal where your workflow depends on memory and manual effort. Of course, too much manual effort can lead to errors, and it might be time to upgrade your CAD management. 3. Standardize Part Numbers and Essential Information Consistent identifiers make product data easier to connect. A part should have a stable, unique part number. Its revision should be tracked separately, so people can distinguish the part’s identity from its approved design state. For example, a bracket might retain part number 100245 as it moves from Revision A to Revision B. A substantially different bracket may require a new part number under your company’s rules. Define those rules early, including when a change warrants a new revision or a new part number. Then establish the minimum information required for a usable part record. Depending on the component, that might include: • Part number and description. • Responsible owner. • Lifecycle status. • Material, finish, or relevant specifications. • Manufacturer and manufacturer part number. • Associated drawings and design references. Keep descriptions consistent enough to support searching and reuse. “Bracket, sensor mount” is easier to interpret than “John’s bracket.” Also standardize drawing templates, CAD properties, units, and commonly used library components. Assign someone to maintain these conventions and resolve exceptions. Duro’s SolidWorks integration supports PLM-based part numbering and management of file metadata, helping teams establish consistent information across their design and product records. 4. Separate Work in Progress From Released Designs The newest design is not always the design your manufacturer should build. For example, engineering might be developing Revision C while a supplier is still producing an approved batch of Revision B. Both states need to remain identifiable. Establish a simple lifecycle, such as: In Work → In Review → Released → Obsolete Define what each state means, who can move a design between states, and what information must be complete before release. It also helps to distinguish a working version from a released revision . Engineers may save many versions while developing a design. A released revision represents an approved state that others can reference for a specific purpose. Your CAD or PDM system should provide appropriate controls for active work, including management of file references and concurrent editing. Your release process should preserve the approved record and prevent subsequent edits from silently changing what others believe they are building. And a pro tip: avoid using filenames such as final_v7_USE_THIS as the primary way to communicate approval. Make status and revision explicit in the managed record, not baked into file names. 5. Keep CAD, BOMs, and Manufacturing Files Aligned A CAD model can be correct while the build package is wrong. The drawing may reference an earlier design. The BOM may specify an outdated connector. The STEP file may have been exported before the final change. Treat a release as a coordinated set of information. Before approving it, verify that: • Models and drawings represent the intended design. • BOM quantities and component revisions are correct. • Manufacturing outputs come from the approved source. • Mechanical and electrical interfaces have been checked. • Required documentation is included. For an electromechanical product, this could mean checking that a PCB’s connector position matches the enclosure opening and that both belong to the intended product configuration. Also review what the CAD-generated BOM leaves out. Adhesives, labels, packaging, and other necessary items may require additional records. Duro provides a place to bring product information from different engineering disciplines together. Its Altium 365 integration , for example, supports structured eBOM generation and publication of associated schematics, PCB information, and manufacturing files. The practical benefit is a more consistent handoff from engineering to the people responsible for sourcing and manufacturing. 6. Create a Lightweight Release and Change Process A startup needs clear decisions and accountable owners. The approval process can remain small, because that’s the best way to keep moving quickly. For an initial release, identify who checks the design, who approves it, and what constitutes a complete package. For changes to released designs, record: • What changed: The affected parts, assemblies, documents, and revisions. • Why it changed: The problem, requirement, or improvement driving the update. • Who approves: The people responsible for reviewing its technical and operational impact. • When it applies: The build, order, date, or other defined point at which the change takes effect. • What happens to existing material: Whether inventory and work in progress can be used, reworked, or need another disposition. • Who needs notification: Purchasing, manufacturing, suppliers, and other affected stakeholders. For example, consider a connector substitution. Engineering needs to check electrical and mechanical compatibility. Purchasing needs the new sourcing information. Manufacturing needs to know which builds use the replacement. Recording those decisions prevents the team from repeatedly reconstructing them later. Duro’s change orders provide a structured process for proposing, reviewing, and approving product changes, with traceability of the decisions. Teams establishing their first process can also use Duro’s free change order template to define the information they need to capture. 7. Make Approved Information Easy to Find Engineers shouldn’t have to act as a help desk for every drawing request. Purchasing needs component information. Operations needs release status. Manufacturing needs approved drawings and production files. Each group should have a clear path to the information relevant to its work. Establish where approved information is published and how people access it. Give users appropriate permissions, clearly identify superseded revisions, and define how external partners receive release packages. When sending files to suppliers, include an explicit record of the part numbers and revisions being delivered. Confirm receipt and resolve any ambiguity before production begins. 8. Automate Repetitive Handoffs Once your workflow is clear, look for copying that’s repeated. Common examples include transferring part numbers, entering CAD properties into a spreadsheet, rebuilding BOMs, and collecting production files for release. These are useful candidates for integration. First, decide which system owns each type of information. For example, your CAD environment might own design geometry, PLM might own approved product revisions and engineering changes , and ERP might own purchasing transactions. Then define when information moves and who checks the result. A PLM platform like Duro does this all for you because it offers integrations with SolidWorks, Onshape, NX, and Altium 365, alongside connections to ERP and MES systems. Its CAD-agnostic approach allows teams to build a workflow around a mixed engineering stack. Check each integration against your actual workflow, including configurations, assemblies, metadata, and required file formats. Assign someone to resolve failed transfers or incomplete records. Automation is most useful when ownership and release rules are already clear. 9. Start With One Product and Expand You can improve CAD management without reorganizing every historical project. Choose an active product or assembly that involves a meaningful handoff to purchasing or manufacturing. Then: • Identify its current approved design and BOM. • Resolve duplicate part numbers and missing information. • Establish lifecycle states and approval responsibilities. • Connect the relevant CAD and product records. • Run a release through the workflow. • Process a subsequent change and check whether downstream teams received the right information. It’s best to document the workflow in a short guide and make it part of onboarding. A new engineer should be able to understand how to create a part, submit a design for review, and find an approved release. Track a few practical measures: time spent finding approved information, preparing release packages, reconciling BOMs, and correcting revision mistakes. Those measures will show whether the new process is helping. Build a CAD Management Process Your Team Can Grow With Good CAD management lets scaling hardware companies develop designs faster while giving the rest of its team confidence in the information they use. For a growing hardware team, that starts with consistent identifiers, clear ownership, controlled releases, and reliable handoffs. As manual coordination becomes harder to sustain, PLM helps connect those practices across products and departments. Duro brings CAD releases, BOMs, product records, and engineering changes into a connected workflow. Explore Duro’s CAD integrations to see how your existing tools can support a more manageable path from design to production. Frequently Asked Questions What is CAD management? CAD management is the process of organizing, protecting, reviewing, and sharing CAD designs and their associated information. It includes file organization, design references, metadata, revisions, access, and engineering releases. What is the difference between PDM and PLM? PDM generally focuses on design files and engineering work in progress. PLM connects product information across a broader lifecycle, including BOMs, sourcing, approvals, releases, and engineering changes. Teams often use them together, and capabilities vary by platform. When should a hardware startup move beyond spreadsheets? Consider a more structured system when your team repeatedly reconciles conflicting BOMs, struggles to identify approved revisions, loses track of approvals, or spends too much time preparing manufacturing packages. The trigger is the difficulty of coordinating the work. Can a team manage multiple CAD systems together? Yes. Engineers can continue working in different CAD applications while using a connected product management process for released information.

Autodesk · Oct 28, 2026

CAD, CAE & Simulation

Search for keywords in videos, presentation slides and handouts: • Overview 0 results • Video 1 h 55 min 49 sec 0 results Description Hear from Autodesk's industry leaders as they bring Autodesk's AI into sharper focus through the lens of your industries: design and manufacturing; architecture, engineering, construction; operations; and media and entertainment. Learn how the capabilities introduced on Day 1 translate into real-world productivity gains, more connected workflows, and new opportunities for you to create and build more. Key Learnings Speakers Andrew Anagnost Dr. Andrew Anagnost’s career spans more than 25 years of product, business, and marketing experience focused on driving strategy, transformation, and product development — and includes positions at Autodesk, Lockheed Aeronautical Systems Company, and EXA Corporation. He also completed a doctorate degree at Stanford University and worked at NASA Ames Research Center as an NRC post-doctoral fellow. Andrew began his career at Autodesk in 1997 and has held a wide range of roles in the areas of marketing, new business development, product management, and product development. Prior to becoming president and CEO in June 2017, he served as chief marketing officer and SVP of the business strategy & marketing organization. In this role, Andrew served as architect and leader of Autodesk’s business model transition—moving the company to become a software-as-a-service (SaaS) solutions provider. Previously, Andrew held various executive positions across Autodesk. Early in his Autodesk career, he led the development of the company’s manufacturing products and grew Autodesk Inventor revenue to over $500 million. Andrew is a member of the Autodesk Board of Directors and joined the board of directors of HubSpot, Inc. in September 2023. He holds a bachelor’s degree in mechanical engineering from California State University, Northridge (CSUN), and holds both a master’s degree in engineering science and a PhD in aeronautical engineering and computer science from Stanford University. • SH Stephen Hooper Stephen Hooper is Vice President of Design & Manufacturing software development. Stephen has over 26 years of industry experience working for companies ranging from suppliers of industrial machinery to a software vendor of market leading solutions. Stephen started his career as a mechanical design engineer working in the UK and later relocating to the US to work for Autodesk. Experienced at every stage of the product development, marketing and sales process, from end user, through to software vendor, Stephen relishes the challenge of working in a fast moving, growth orientated environment, targeted at servicing the needs of high profile customers and partners. • DC Diana Colella Diana Colella manages product, strategy, and execution for the company’s media and entertainment portfolio servicing the film, TV, and games industries. Diana has been with Autodesk for more than 20 years occupying a range of leadership roles, including head of product management and worldwide support. She has extensive experience in strategically transforming business models, creating new product offerings, and optimizing processes on a global scale. • JK Jeff Kinder Jeff Kinder leads strategy and execution across Autodesk’s design and manufacturing portfolio. With a forward-looking focus on speed, data, cloud-based workflows, user experience, flexible business models, and customer outcomes, Jeff is helping to catalyze the Management in manufacturing. Jeff previously served as chief digital officer for Autodesk and oversaw the company’s digital platforms and customer experience. In this role, he was responsible for creating the connective tissue between the company’s customers, products, and data. His responsibilities included building end-to-end digital platforms – from customer data and self-service to entitlements and licensing, to modern enterprise applications such as identity, order, and financial systems. He also led Autodesk’s business model transformation. Prior to joining Autodesk in 2018, Jeff led large-scale, customer-focused Managements across a range of industries. • AB Amy Bunszel As Vice President of the AutoCAD Product Line Group, Amy Bunszel leads the product team responsible for producing a wide variety of AutoCAD products running on desktop, web and mobile platforms. These products represent over $1B in revenue for Autodesk and through AutoCAD 360 over 40 million DWG files have been uploaded to the Autodesk Cloud and are leveraged by over 2.5M unique users of our web and mobile applications each month. Amy’s roots are in Applications Engineering and Product Management and she now runs a cross functional team of over 350 people responsible for delivering over 10 varieties of AutoCAD products Video Player is loading. 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Transcript \[MUSIC PLAYING\] NARRATOR:Lenovo.Lenovo. \[AUDIO LOGO\] \[MUSIC PLAYING\] NARRATOR:Welcome.Youmadeit.We'resohappyyou'rehere.ConsiderthisausermanualforplanetEarth.Asimpleguidethatbeginslikethis.Makesomethingafastthing.Abigthing.Youcanmaketinythingstoo. You'llmakemistakes.That'scalledprogress.Andwhenyoufinish,maketimetostandback,andmarvelatwhatyou'vedone.Afterall,thisbigworldwecallhomeisyoursforthemaking.Somakewhatmatters.Wethinkyou'rereallygoingtoithere. ANNOUNCER:Please,welcomebackAutodeskpresidentandCEOAndrewAnagnost. \[MUSIC PLAYING\] ANDREW ANAGNOST:Goodmorning. \[APPLAUSE\] Goodmorning,everybody.Welcometodaytwo.Ihopeyou'refeelingOK.Sinceit'sVegas,I'mgoingtotakealittlebitofagamble.It'salsoyourchancetomesswithmeifyouwantto.SowhatIwantyoutodoisIwantyoutoclapwhenIhityourrange.SoI'mgoingtodoarangefrom1to10.Iwanttohearhowyourdayonewas.SoI'mgoingtogivesomecategories,andclapwhenIhityourrange. Sothinkofanumber.Rateyourdayone.Allright.Sohowmanyofyouareinonetofive?Let'stalklater.Wewillfindyouandtalk,andfindoutwhat'sgoingonthere.Allright.Fivetoseven. \[APPLAUSE\] OK.OK.That'sgood.7to10. \[APPLAUSE, CHEERING\] Thefrontrowismakingithardformetotellwhat'sgoingonintheback. \[APPLAUSE, CHEERING\] Allright.I'mgoingtotakethatasawin.Gamblepaidoff.I'mnottooembarrassed.Iwanttotalktotheonetofivepeople,becausethatmeansthere'ssomethingwegottodobetter.Wealwayslikethat.Soyesterday,wetalkedaboutwhat'spossiblewhenyouunlockcapacity? IhopeyousawhowAIiseliminatinggruntwork.Helpingyoubecomemoreproductive,morecreative,andmoreinnovative.Andyousawhowunlockingcapacitydoesn'thavetostopwithorganizations.Itcanextendtoentireprojectecosystems,becausewhendataflowsseamlesslyacrossandbetweencompanies,everyonecancommitfewerresourcesperproject,bidonmoreprojects,andwinwithgreaterconfidence. Beforewediveintotoday'skeynote,Ireallythinkit'simportanttocelebratetherealheroesofthisstory.You'reallheretoday.Andactually,manyofyouarepartofTIME'slatesteditorialist,TIMETrailblazers,andtheAutodeskdesignandmakeawards.Theseweretworecognitionprogramsthatcelebratepeople,andideasshapingthefutureofdesignandmake. IwanttohighlightthreecompaniesI'mparticularlyimpressedwith.ThefirstoneistheFoothillCatalogFoundation.They'reacceleratingrebuildinginwildfire-affectedareaslikeLosAngeles.BackedbyAutodesk,they'recreatingafirstofakindcatalog,apre-approvedhomedesigns.It'sco-developedwithcommunities. Thesedesignsarecuttingpermittingtimelinesfromoverayeartoweeks.Andtheyreducepre-constructioncostsforthesurvivorsbyupto95%. \[APPLAUSE\] Ihadachancetomeetwiththetwofounders.They'reamazingyoungpeople.Andtheyareyoung.They'realsomarried.Payattentiontothatmarriagewhileyouworkthecompanyproblemtoo.Staystrongtogether. StellarCreativeLabcreatedaconnectedanimationpipelinestobringMarvelZombiestolife.Ilovethatline.Bringingzombiestolife.They'reusingAutodesktoolstoconnectartists,assets,andproductionacrossthestudio.It'sagreatexampleofthefutureofanimation,wherescalable,collaborativeworkflowssupportthepaceandcreativedemandsofepisodicTV.Solet'sgivethemahandtoo. \[APPLAUSE\] AndKheyti,astartupfromIndia,helpsfarmers-- \[APPLAUSE, CHEERING\] --adapttoclimatechange.It'sgreenhouseinabox.It'sanaffordablefarmingasolutionthatcombinestechnologywithtrainingandsupport.KheytiispartneringwithAutodesktostrengthenitsphysicalproductanddigitalsystems,hopingtoreach1 millionfarmersby2030.Let'sgivethemahandtoo. \[APPLAUSE\] ForcompanieslikeKheyti,TheFoothillCatalogFoundation,andStellarCreativeLab,morecapacityisn'tanabstractidea.Ithasmadearealimpact.Butcapacityisn'tunlockedallatonce,it'sbuilt.Stepbystep,workflowbyworkflow. Sotoday,ourleaderswillshowyouhoweachandeveryoneofyoucanunlockcapacitywithinyourindustrystartingwithmediaandentertainment.PleasewelcomeDianaColella. \[MUSIC PLAYING, APPLAUSE, CHEERING\] DIANA COLELLA:Foralongtime,makingamovieoragametookeitheraverylargebudgetoryearsofyourlife.Sometimesboth.That'schanging.Anewgenerationofcreatorsaredoingbigthings.You'vegotYouTubeShortsreachingbillionsofpeople.Indiegameswithmassiveplayerbases.Andalowbudgetmoviebreakingboxofficerecords. Theydon'tneedagreenlightfromastudio.YouTubeandSteamgivethemaccesstoaudiences,andAutodeskgivesthemaccesstothetoolstheyneedtomakeithappen.NewtoolslikeAutodeskFlowandAIthatturnedmonthsofproductionintoweeks,evendays. Theyunlockcapacitytoputmoreofyourimaginationintoyourfirstscene,yourfirstlevel,ortheworldofyourstoryfaster.Allyouneedistalent,andastorytotell.Today,morepeoplecanmakethemovieorgamethattheydreamabout.Evenme. Sotoday,Ihaveactuallybeenworkingonashortmovie.It'scalledRobotsoftheWildWest.It'sabouttworobots,soRustyandLasso Lizfightingtosavetheirtownfromaruthlessgoldminer.Ofcourse,theybeathimagainstallodds,andtheyfallinlovewhiledoingso.Allright.Iknow.I know.I know. Allright.Sofirstchallenge.Robotsareexpensivetomake.Idon'thaveamassivevisualeffectsbudget,butIhaveastory,andIwanttotellitwithFlow.NowIcan.I'mgoingtoaskNikola,VPofEmergingTechnologyandthecreatorofFlowStudiotohelpme. \[APPLAUSE\] Hey,Nikola. NIKOLA TODOROVIC:Hi,Diana.Happytohelp. DIANA COLELLA:All right. NIKOLA TODOROVIC:Allright.Westartedonthecharacters,andwealreadylockedinLassoLiz--asyoucanseehere--andRusty,ourherocharacters. DIANA COLELLA:OK.Good. NIKOLA TODOROVIC:Let'screateavillainnow. DIANA COLELLA:Allright.Sobeforewedothat,Nikola,howhardisittocreatethesecharacters? NIKOLA TODOROVIC:Traditionally,it'squitehard.Itcantakesometimesdaysandweekstoiterateon3Ddesigns.ButwithFlowStudio,one,the3Dtools,wecangenerateimagesanddesignsandconceptsreallyquick,andthenturnitinto3Dmodels.Sowecanmovemuch,muchquicker.Solet'sdothat. I'mgoingtoopenourtexttoimage.Andhere,I'mgoingtouseNanoBananatogetsomepromptsin,andgenerateacoupleimages,sowecanagreeonthedesign.AndbecauseFlowStudioisaweb-basedsolution,Icandomultipleofthematonce.SoletmeshowyousomeexamplesherethatIhave,andyoucantellmewhatyouthink. DIANA COLELLA:OK. NIKOLA TODOROVIC:Let'sstartwiththisonehere.Whatdoyouthink? DIANA COLELLA:No. NIKOLA TODOROVIC:No. DIANA COLELLA:No. NIKOLA TODOROVIC:Imean,enough.OK,Igotbetter.Whataboutthisguy? DIANA COLELLA:OK.Seriously. NIKOLA TODOROVIC:Youdon'tlikethemustache? DIANA COLELLA:OK,look. NIKOLA TODOROVIC:Andhesays toughcall. DIANA COLELLA:I'mthedirector.Let'sgo. NIKOLA TODOROVIC:Allright.We'llremovethatone. DIANA COLELLA:No. NIKOLA TODOROVIC:Whataboutthisguy? DIANA COLELLA:Thisguyisactuallyawesome.Helooksmean,whichisexactlywhatwewantthevillaintolooklike. NIKOLA TODOROVIC:OK,perfect.Soit'squiteeasy.Oncewegetanimage,Icanjustselectusers3Dinput,andthenIcangiveitaname,andjustpressgenerateamesh.Andthen,we'regoingtostartgeneratinga3Dversionofthatimage. DIANA COLELLA:Allright.SoNikola,allthesecharactersthatyou'vecreated,canIactuallyusethemforagametoo? NIKOLA TODOROVIC:Yeah,absolutely. DIANA COLELLA:OK.Good.Becausetoday,wehavetorecreatethemtogofromamovietoagame,whichobviouslyisprettyinefficient. NIKOLA TODOROVIC:Yeah,noneedtorecreate.OurAIdoesn'tjustgenerateamodel,italsorigsit,soyoucanexportit.Anduseitinagame,youcanevenexportitinUnrealEngine. DIANA COLELLA:OK,great.Great.OK.Sonowthatwehavethecharactersdone,weneedtocapturetheactor'sperformance.Sowe'regoingtoneedyoutodothat.He'swiththeproductioncrewinSanFranciscoshootingthemocapdata.Sohewantsmydirectionontheactor'sperformance. NIKOLA TODOROVIC:OK.Soundsgood.LetmejustopenFlowCapturerooms,andwegotHugh. DIANA COLELLA:Allright.Hi,Hugh.How'stheshootgoing? HUEY CALVELEY:It'sgoinggreat.WehavetwolivecamerafeedssetupinFlowCapture,soyoucanseewhatthecamerassee.Andnowthatyou'rehere,let'sshootthescenewhereRustyentersthesaloon,playedbyVijay.OK,let'sdoit.Rollcameras. CREW:Rolling. CREW:Speeding. HUEY CALVELEY:Andaction. \[DOOR OPENS\] Andcut. DIANA COLELLA:Allright.OK. \[LAUGHTER\] Let'sdoitagain,VJ.Sopausewhenyouenter,lookaround.Alittlebitmoreenergy. \[LAUGHTER\] HUEY CALVELEY:Youheardher.Goingagain.Rollcameras. CREW:Rolling. CREW:Cameraspeeds. HUEY CALVELEY:Andaction. \[DOOR OPENS\] Cut.How'sthat? DIANA COLELLA:OK.Loveit.Let'slockitin. HUEY CALVELEY:Perfect.It'sinNikola'sinboxalready,alongwithsomeothertags. DIANA COLELLA:Thankyou.Hughallright.So-- NIKOLA TODOROVIC:Thankyou, Hugh. DIANA COLELLA:--that'swascool.Igettotellpeoplewhattodofromastageinuse.SothatwasgreatwithFlowCapture.That'sawesome.Nikola,what'snext? NIKOLA TODOROVIC:OK,nowthatwehaveperformance,andwehavethecharacterdesign,let'sopenour3Deditor--it'sthenewestflowstudiotool--andIcancombinenowmultiplesourcesinhere,includinganimation,character,etcetera. SoI'mgoingtostartwithaddingourwonderhuman.Thisisourtemplatecharacter.I'mgoingtouseit,andI'mgoingtoreplaceitlaterwithourrobotcharacter.Butfirst,letmeapplyanimationtoit.SoIhavetheshotsthatHughsentmeearlier,andwehavesomethingcalledImotioncapture,whichtakesavideoandanalyzestheperformance,andthenturnsitintoa3Danimation. SoallIhavetodoisjustclickAddtoStage,Apply.Andthenjustlikethat,Ihavetheanimationfromthatperformancewejustsaw.Buthe'smissingsomething.He'smissingaworld.Solet'sgiveitaworld.SowhatIwoulddohereisIwouldusemarble,byWorldLabs. Andmarbleisamodelthatcreatesworldsfromimagesorprompt.Andinthiscase,aswe know,haveasaloon.SoIwouldgiveitasaloonimage,andthenpressgenerate.Andsomethinglikethistakesaboutthreetofiveminutes.Butjustlikewithcharacters,itsavesmealotoftimetoiterate.Icouldgoquickly. Becausetraditionally,creatingaworldisevenmorecomplicatedsometimesthanthecharacters.SoIhavethatpreloadedearlier.Sogoingtoshowyouwhatthatlookslike.Sowehavehimnowintheworldhere,andwehavetheanimation.AndwhatIreallyneedyourhelpwithisthecamera.Solet'sgiveitacamerahere.I'mgoingtocreateacamera,andyoutellmewhatwe'rethinking.Startwidemaybe? DIANA COLELLA:Yeah.Sostartwide.Andthen,whenhestops,likepushingclose,andsowecanmakehisentrancemoredramatic. NIKOLA TODOROVIC:Gotit.Sowe'regoingtogiveitonekeyframehere,andanotheroneandthenpushabit.Maybesomethinglikethis. DIANA COLELLA:Yeah. NIKOLA TODOROVIC:Letmejustplayit. DIANA COLELLA:OK. NIKOLA TODOROVIC:Andaslownicelittlepush-in. DIANA COLELLA:Yep.Yeah. NIKOLA TODOROVIC:That'sgood. DIANA COLELLA:Thatworks.Thatworks. NIKOLA TODOROVIC:ThisiswhatIlikeabout3Deditor.Inacoupleofminutes,Icanpreciselylockintheshot,thecameramove,theanimation,andworldcombines.AndonceI'mdonewithit,whatIwoulddoisIwouldsendthattoCanvas.AndwhatCanvasis--Canvasisournode-basedsolutionwhereessentially,Icangiveitmultiplesources. SoIcangiveitanimagesource,Icangiveitavideosource,andreferences.Sointhiscase,wehavethatvideothatweloaded.Andthen,I'mgoingtogiveitanimagereferenceofasaloon,andI'mgoingtogiveitanimagereferenceofourcharacter. Andessentially,onceIcombinethatIbasicallytellavideomodel,hey,usethesereferences,usethisimage,andreplaceourwonderhumanwithit,andyougetsomethinglikethis.Herewego. DIANA COLELLA:Yeah,thatlooksgood. NIKOLA TODOROVIC:He'slookingaround,andthenhespotstheloveofhislife, right? DIANA COLELLA:Yeah. NIKOLA TODOROVIC:AndthebeautyoftheCanvasis,thisisjustoneworkflow.Idon'thavetogo3Dto2D.IcaniterateallinCanvas.SowhatIcando,I'llshowyouacoupleexampleshere.WhatIcandoisIcanactuallystartwithalotofimages.Andit'saninfiniteCanvas,soIcanreallyiteratealotofdesign.Mood,bored,etcetera. AndIcanalsostartwithanimage.Idon'thavetostartwith3D,Ijuststartanimage.IfIfittedthisimage,Icanstartanimage,andgiveitalittlebitmore-- DIANA COLELLA:Oh,it's huge. NIKOLA TODOROVIC:--even more dramaticrustymoment.Ithinkhe'sdepressedhere.Oh,heleft?Sheleft him? DIANA COLELLA:Huge. NIKOLA TODOROVIC:Sheleft him? DIANA COLELLA:No. NIKOLA TODOROVIC:No, shedidn'tleavehim. DIANA COLELLA:Hey,don't tellthemthestory. NIKOLA TODOROVIC:OKsorry,sorry. \[LAUGHTER\] DIANA COLELLA:Allright. NIKOLA TODOROVIC:AndsothewayIliketothinkaboutit,Iuse3DeditorwhenIwantprecisionandcontrol.AndIuseCanvaswhenIwantspeed. DIANA COLELLA:Allright.Sotalkingaboutspeed,wenowneedahorse,whichbytheway,isverydifficulttoshootthem. NIKOLA TODOROVIC:We'rebringingahorse? DIANA COLELLA:No.Nohorse.No.No.SoI'veaskedLancetoanimateitinMayausingthenewmotionmakertool.Solet'stakealook. \[VIDEO PLAYBACK\] -Hey,Diana.We'vebeenworkingonyourrunawayhorsescene.Mayaishonestlyperfectforsomethinglikethis.Yougetcompletecontrol,andmotionmakermakesthesetupfast.Noneedtosittheremanuallykeyframingjusttogetitmoving.Justgiveitapath,soitknowswheretogo.Thenyoucanchangethetiming. Speedituporslowitdown.Walktoagallop,andwithmotionmaker,youcanevenmakeitjump,orchangedirection.Ithandlesthetediouswork,andstillgivesyouanimationcurvesthatyoucanrefineandaddpersonalityto. Motionmakergetsyoumovingfaster.Mayakeepstheartistincontrol. \[END PLAYBACK\] DIANA COLELLA:OK.Thehorselooksgood. NIKOLA TODOROVIC:Looksgreat. DIANA COLELLA:We'regood. We're good. NIKOLA TODOROVIC:Looksgreat. DIANA COLELLA:All right, Nikola.Sonowlet'sshoweveryone.Let'sputitalltogether. NIKOLA TODOROVIC:Awesome.Let'stakealook. \[VIDEO PLAYBACK\] \[MUSIC PLAYING\] -Areyoustillgoingtothe-- \[BEER POURING\] --goingtotheAutodeskkey night? -Yes,Iam,butIdon'thavearide. -WellI'llbe.Wecantakemyride.He'soutside. \[NEIGHING\] -Yourhorseisrunningaway. \[GALLOPING, MUSIC PLAYING\] \[END PLAYBACK\] DIANA COLELLA:Wow.That'samazing.Iloveit.Iloveit.Soanyway,Ican'twaittoseeitwiththevillain.SothankyouNicola.Greatteam.That'sawrap for today. NIKOLA TODOROVIC:Thanks,Diana. DIANA COLELLA:Thankyou. NIKOLA TODOROVIC:OK. \[APPLAUSE, CHEERING\] DIANA COLELLA:Allright.It'samazingwhattechnologycanhelpyoudotoday.Wejustwatchedwhat'spossiblewithtoolslikeFlowCapture,Maya,andFlowStudio,andtheirAIcapabilities.AIispowerful,butitdoesn'treplacetheartistsorwritethescript. AIhelpsusgofaster,bemorecreativesowecantrysomething,throwitout,andtryagainwithoutalwaysneedingmonthsofwork.Amassivecreworabigbudget.AIunlocksthecapacitytodomore,exploremoreideas,testmoreoptions,andreachbetteroutcomesfaster. Thisisn'tuniquetofilmmaking.It'sthesamestoryplayingoutacrossallindustriesweserve.Nextup,pleasewelcomeJeffKinder,EVPofdesignandmanufacturing. \[MUSIC PLAYING, APPLAUSE, CHEERING\] Thankyou. JEFF KINDER:LookwhatIhaveforyou. DIANA COLELLA:Socool.Yes.That'ssocool.By the way,thanksforthegift. JEFF KINDER:Yourteamaskedminetotaketherobotdesigninfusionand3Dprintit. DIANA COLELLA:Well, you know,Fusionisusedingamesandfilmtoo.Allright. JEFF KINDER:Iloveit.Iloveit. DIANA COLELLA:I'llleaveyoutoit. JEFF KINDER:Thankyouverymuch. DIANA COLELLA:Bye. \[APPLAUSE, CHEERING\] Wow.M&Eisalwayssuchatoughacttofollow.Imean,films,games,sizzle.Butseriously,today,theyjustmadeamovie,oratleastpartofamoviein12minutes.Imean,that'samazing.Dianashoweduswhat'spossible,orhowAIisexpandingwhat'spossibleinthestorieswetellandtheexperienceswecreate. It'sthesamefortheproductswedesignandmanufacture,theproductsyouuseeveryday.AIallowsustoturnmoreideasintobetterproductsfaster.Butit'seasiersaidthandoneaswe'relearning. Productsarephysical.They'recomplex.Theydemandprecision.Thousandsofpartscomingtogetherinafinishedassembly.ThisiswheregeneralizedAImodelsstruggle.Todesignandmanufacturebetterproducts,ittakesAIforthebuiltworldwithprojectintelligencepoweredbyindustry,andcompanyspecificcontext. Lastyear,ItalkedabouthowIwas--I wastalkingaboutAIasthenextparadigmshiftindesignandmanufacturing.Icanreporttoyoutodaywe'reseeingthatshiftaccelerate.JDDFurnitureisusingAutodeskAIdaily,specificallyAutoConstrain. They'venotonlyincreasedtheirproductivity,butthey'vealsominimizedmistakesalongtheway.WetSoundsisleveragingAutodeskassistanttodesigntheirpowersportsstereosystems.Theyuseassistanttoautomatetasksnoonewantstodosavingsignificanttimeintheoverallprocess. Somanyofyouhavemovedbeyondexperimentationintoadoption,whichisnotsurprising.Manufacturinghaslongembracednewtechnologies,andit'sagloballycompetitiveworld.Youneedeveryedgeinproductivity.OurgoalistotakeAIevenfurthertohelpyourbusiness. AndFusion,ourindustrycloudfordesignandmanufacturingsitsattheheartofthis.We'reproudthatFusioncontinuestobetheindustry'smostcomplete,andfastestgrowingsolution.It'salsoleadingthepackindeliveringAIcapabilities. Butbeforewediveintothose,let'smeetThomasSaierfromO'NEAL.HisteamusesFusionforvisualization,design,engineering,andglobalmanufacturing.Theresultisasmarterhelmetthatacceleratesemergencyresponseswhilealsolookingprettyincredible.Let'stakealook. \[VIDEO PLAYBACK\] -Getready. -Comeon.Let's go. -Youcan'ttellpeoplenottotakerisks.Mykidscertainlywouldn'tlisten.Peoplearegoingtoride.They'regoingtorace.Myjobisn'ttostopthat,myjobistomakeitsafer. ThemissionstatementofEDERASafetyandO'NEAListocreateproductsthatgobeyondstandards.AndI'minthepositionofprovidingequipment,whichpotentiallycansavelives. You know,justpopthemin. Innovationisn'taboutmakingmorethings.It'saboutgettingmoreoftherightideasintotheworld.Oneofthemostexcitingprojectswe'reworkingrightnowistheSL2fullfacedownhillmountainbikehelmet,whichisverylightweight,butextremelystable. UsingFusion,wedesignedbrandnewsafetyfeaturesstartingfrompassiveprotectivesystems,likethecrashcells,whichhelpdeflectimpactallthewayuptoactivesensorsystems.Soifaridercrashes,theelectronicsaredesignedtoalertsomeone. Here are the recess. You'redealingwithindustrialdesign,mechanicalengineering,electronicsmanufacturing,andsomehowallofthishastobecomeoneproduct.That'swhyFusionworkssoperfectly,becauseyouhavethisbeautifulmixofcloud-basedengineering. -\[INAUDIBLE\] -IntheageofAI,speedmatters.Youtrysomething,youlearnfromit,andyouchangeit,andyoudothatagainandagain.WithFusion,wecaniteratefaster,andcollaboratebetterandtestsooner.Youcanspendmonthsthinkingaboutallthedetailsofadesign,buteventually,youstopseeingtheproduct,andyouseethepersonit'sprotecting.That'swhenyourememberwhytheideamatteredinthefirstplace. \[END PLAYBACK\] \[APPLAUSE, CHEERING\] JEFF KINDER:Whatdoyouthink? \[APPLAUSE\] DidIoverpromise?Formandfunction.DesignedandmadeinFusion. \[APPLAUSE\] IhopeTommyletsmekeepit.O'NEALstoryisapowerfulreminderthatinnovationisaboutgettingmoreoftherightideasintotheworld,andwe'reproudthatFusionispartofthat.Solet'stakealooknowathowFusioncanhelpyou,howitcanunlockcapacityforindividuals,forcompanies.Andforentireproductecosystems. Forindividuals,I'mgoingtotalkaboutAIanddesignandAIandmanufacturing.Forcompanies,I'mgoingtotalkaboutdata,AIandthedigitalthreadtheyproduce.Andforproductecosystems,I'mgoingtotalkaboutAIinproductlifecyclemanagement.Let'sstartwithAIanddesign. Yesterday,AndrewpreviewedFusion'sindustryleadingAIcapabilities.I'mexcitedtodivedeeperintothose,andmoretoday,includinglivedemos.Whoheremowedlawnsasasummerjob?Showofhands.IgrewupintheMidwest.Bigyards,lotsofgrass. Iwalkedaroundmyneighborhoodattheageof10,puttingflyersinmailboxes,postingthemontelephonepoles,offeringmylawnservices.Inhighschool,Ievengraduatedtothecountyparksandrecreationdepartment.Truestory. Well,whatwe'regoingtouse,andwhatwe'regoingtousingtodemoFusiontodaycouldhaveputmeoutofbusiness.Forourfirstdemo,I'llhanditovertooneofourFusionexperts,Richard. \[APPLAUSE\] RICHARD STUBLEY:Perfect.Thankssomuch,Jeff.Now,yesterdayyousawthelawnmower,andtodaywe'regoingtoexpandonitalittlebitmore,andshowyouhowFusionbroughtittolife.Now,whileJeffwasoffmowinglawnsashissummerjob,minewasalittlebitcooler.Iwasatechnicalapprenticeinadesignofficeworkingonlargeassembliesfortoolingsystems. Somuchofthatworkwasaddingnewpartstoassemblies.Manual,repetitive,andjuststiflingmycreativity.Foranyofyououttherefeelingthatexactsamepain,don'tworry,we'vebuiltautoassemble.Let'sseehowitworks.Somynexttaskistofinishoffthistopcover. Now,mycolleaguehasalreadydesignedthehinges.Therearecommonproductsthatweuseacrossourentireproductline.I'mgoingtoinsertthemintoFusionnow.Butmostimportantly,I'mnotgoingtogiveanyindicationofwheretheybelong.Now,thisisn'tguesswork.Autoassembleisbuiltfromthegroundupusingourveryownindustryfoundationmodel. Wecanseethere,it'salreadyfoundthefourlocationsthehingesneedtobe.Amazing.Let'sbringthemallin.Ibringthemin,andchecktheywork.Ah,perfect.ExactlywhatIwanted.Let'sstopandthinkaboutthatforasecond.Ithappenedsohappenssoquickly.There'sfourhingesonthatpart.There's12selectionsrequiredperhinge.That's48manualselectionsInolongerhavetodomyself. IcanalreadyfeelJeffthinkingaboutrecalibratingmyperformancetargets.ThisisperfectwhenI'mdoingthedailygrindofinsertingonepartafteranother.Butwhataboutanentiresubassembly?Let'sjumpbacktoourlawnmower,andtakealookunderneath. Sohere,wehaveourfrontcasterwheel.Now,thisisa bought-inpart.Wedon'tmakethis.ItgetsimportedfromanotherCADsystem.Andbecauseofthatallthepartsarefloating.They'reloose.Andspeakingfromfirsthand,thisisextremelyfraughtwithdanger. AndthelastthingIwanttobedoingisspendingmydaysrebuildingassembliesthatsomeoneelsehasalreadydone.Solet'sgetautoassembletodoitforus.Autoassemblenow,foracarefullycuratedcontext,isgoingtoanalyzethisassembly.It'sgoingtoworkouthowthatovercenterlinkageshouldactuallybebuiltanddoitforme. AndwhileI'vebeentalking,therewehaveit.Now,oneofthemostimportantthingstorecognizehereisit'snotcreatedaspider'swebofconstraints,sohardtomanageIcan'tdealwiththemmyself.It'sbuiltitusinglogicalgroupsexactlylikeI'dhavedonemyself.Perfect. Weseethelinkageworkscorrectly,andlet'scheckthattheyoke--yeah,that'sspinningaround.Andsodoesthewheel.Thisisamazing.Butforanyofyououtthereworkingwithsupplierdata,itgetsevenbetter.Let'sjumpbacktothelawnmower. Now,afewdaysago,wehadaproductreviewonthis,andwespottedaproblem.I'llgiveyouahint.Cananyoneelsespotit?Now,Idon'taboutyou,butIwasalwaystaughtdesignsomethinglikeyou'regoingtohavetoassembleit,andyou'regoingtohavetotakeitapart,andthere'snotenoughclearancethere.Weneedtoaskforadesignchange. Solet'squicklylookatthemodel.Again,becausethisissupplierdata,thisiswhatwegetprovidedwith.Canyouspottheproblem?Lookatthetimelineatthebottom.Becauseit'sanimport,allwe'regivenisonebasefeaturetoworkwith.Iwanttheentirehistory.Andthat'swhereautotimelinegenerationcomesin. RebuildingtheparametricDNAofamodel.IfIweretodothismanually,probablyafewdays,andit'saveryriskyprocess.Autotimelinegenerationdoesitinjustafewminutes.I'vegot30secondsleft,soI'mgoingtojumpovertotheoneIgeneratedthismorning. Therewecanseeourlovelytimelinefeature-richandfreeoferrors.Andwecanseeitmakingthepartjustlikeweallwould.Sketches,extrudesfillets,rebuildingthattimelinefromtheimportedmodel.AndbecausetheirnativeFusionfeatures,IbenefitfromallthecoretoolsthatIuseeveryday,likecrosshighlighting. Ichoosetheface.Iseetheextrudefeaturethatit'sreferencing.Icangoin,andwecantake5millimetersoffthatface,andwecangiveourselvesabitofextraclearance.Ah,perfect.Readytosendbacktooursupplier. Sowhetheryou'respendingyourdaysworkingwithsupplierdataorconstrainingmodels,autoassembleandautotimelinegeneration,takedatawithnohistoryornoconstraintsandmakeitusableinstantly.BackwhenIwasadesigner,thiswouldhavesavedmesomuchtime,andisagamechangerforanyengineeroutthere.That'sitfromme.Backtoyou,Jeff. \[APPLAUSE, CHEERING\] JEFF KINDER:ThankyouRichard.Thankyou.WhenIunderstandsthecontextofyourcomplexassemblies,yougetrealvalue.Youcanspeedupyourprocess.Youcantrusttheoutcomesbecausethey'retieddirectlytoFusion.Toyourmodels,yourdata,andyourcontext.That'sprojectintelligence. AndAutodeskAssistantistakingitevenfurther.AssistantletsyouusenaturallanguagetotakefulladvantageofthebreadthofFusion'scapabilities.You'veheardmetalkaboutconfigurationsbefore.They'revariationsofaproduct. Now,AutodeskAssistantinFusionoffersanewwaytocreateconfigurations.Justdescribetherequirementsinsimpleterms,andassistantwillbuildtheconfigurationsforyou.You'llthenbeabletogenerateproductvariationsinseconds.Whetherthat'ssomethinglighter,morecompact,oranall-terrainlawnmower.Solet'sgoalittlecrazy. Whatifwewanttoaddasnowplow--youcantellIgrewupintheMidwest--tothefrontall-terrainlawnmower?You'llbeabletotypethatintoAssistant,uploadanimageifyouwant,andvoila.Fromaprompt,anidea,really,toprecise,fullyeditablegeometryinfusionforanaccessorythatwillfitanexistingdesign.AllofthisdoneintheAssistant. Andbecauseit'saprecisedesignin Fusion,you'llbeabletosenditstraighttotheshopfloor.Now,speakingofwhich,let'smovealongtheend-endprocess,andlookathowAIissuperchargingyourmanufacturingworkflows.Forthat,IwanttobringanotherofourFusionexpertstothestage. DanielflewherestraightfromIMTSS,NorthAmerica'slargestmanufacturingshow,togiveyoualivedemoofourlatestinnovationsfortheshopfloor.Takeitaway,Daniel. \[APPLAUSE\] DANIEL GRAHAM:Thankssomuch,Jeff.Sointhisscenario,I'maproductionplanner,andI'vereceivedaroboticlawnmowerassemblyfrommycolleagueRichard.I'veworkedwithRichardforyears,andItrusthisdesigns,butI'mstillgoingtovalidatethemasIpreparethisformanufacturing. Andtohelpmewiththat,I'mgoingtouseournewAutodesksystemmodeler.It'savisualtoolthatallowsmetocreate,andrunautomations,soIdon'thavetogothroughthisprocessmanually.Thisisfoundationallygoingtochangethewaythatweautomatetheproductdevelopmentprocess.Solet'sstartwiththeCNCparts. I'mgoingtorunthegraph.Andhere,whatyoucanseeisit'sgoingtofindallofthedifferentturnedcomponents,thewheelhubbeingoneofthem.Andit'snotjustfoundthecomponents,it'sapplyingdimensionstolerances,wholeinformationautomaticallyforme. Sohere,youcanseethepart,howit'sheld,andwhereit'slocatedinthemachine.Itevencreatedallofthetoolpathsformesavingmesomuchtime.Now,thenextpartoftheprocess,I'mgoingtouseournewinstantturn-millsimulationcapabilities.Thesewillhelptoensurethatthisrunssafely,andreliablyonmyshopfloor. Now,thisprocesshasonlytakenmeminutesinsideofFusion,whereitwouldhavetakenhoursinatraditionalCADCamtool.Andthebestpartis,myteamnowhasaccesstothesegraphstohelpthemautomatetherestoftheproduct. Solet'stakealookatthesheetmetaldesignnext.I'mgoingtoflipovertothesheetmetaldesign.Andtohelpmewiththis,I'magaingoingtogobackintothesystemmodeler.Thistimethough,I'mgoingtouseoursheetmetalautomationgraph,andI'mgoingtogoaheadandrunthat. Forthoseofyouinmanufacturing, you knowthatsheetmetalcomponentsareusedeverywhere.Andinthislawnmower,it'snoexception.Hereyoucanseethegraphhasfoundallofthedifferentsheetmetalcomponentswithinthisdesign.It'sopeningthem.It'supdatingthem.It'screatingflatpatternsofeachofthem.Andit'sbroughtthemalltogetherintoonedesignforme. Buthere'sthebestpart.We'regoingtouseaFusionnestingcapabilitiestooptimizethelayout,minimizingmaterialwaste.Andthisworkswhetheryou'recreatingaoneofflawnmower,likeIamtoday,orworkinginahighvolumefactory.Fusioncanscalewithyou. Now,theseprofessionallevelmanufacturing,andautomationcapabilitiesinFusionjustmademylifeasaproductionplanner,somucheasier.Allright.Backtoyou,Jeff. \[APPLAUSE\] JEFF KINDER:Thankyou,Daniel. \[APPLAUSE\] AIhandlingrepetitivetasksacrossdesignandmanufacturing.Thatunlockscapacity.Now,we'vespentthelastfewminutes--reallythelastcoupleofdays--bringingthisautonomouslawnmowertolifeinFusion.Whowantstoseetherealthing? \[APPLAUSE, CHEERING\] Allright.Let'sbringitonstage. \[RUMBLING\] It'sactuallycuttinggrassbackthere,Ithink. \[RUMBLING NOISE\] Allright.DesignedandmadeinFusion. \[APPLAUSE, CHEERING\] It'sbiggerthanIthought.Ithinktheysaid1by1 and 1/2.Ithinkmyinternalmetricconversionwasalittlebitoff.Ifyouwanttoseethis,it'llbeontheexpofloorafterthekeynotes.Who'scontrollingthisthing? \[APPLAUSE, LAUGHTER\] Ishouldhaveknown.Ishouldhaveknown.Feelslikeit'sstaringatme.It'salittledisconcertingIthinkforeverybodyinthissideoftheaudience. \[RUMBLING NOISE\] See.Allright. \[RUMBLING NOISE\] Ithinkwe'resafe. \[RUMBLING NOISE\] Stay.Whatyou'vejustwitnessedinourFusiondemosisgroundbreaking.We'reputtingAItoworkunlockingcapacityacrossdesignandmake.Butwe'renotstoppingthere.Ourinvestmentextendstoallthetoolsyouuse,includingInventorandVault.We'reintroducingFusionconnectedclientstoreinforcethebridgebetweenourdesktopapplicationsandourcloud-basedworkflows. InventorisourfirstFusionconnectedclient.We'llmakeitfastandeasyforyoutobuildcustomworkflowsacrosstools.Forexample,you'llbeabletoautomaticallynestyourInventordesign,andhaveitreadytobecutinFusion. AndAutodeskassistantwillacceleratecrossproductworkflowsevenmore.It'llunlockinventorsrobustAPIstoimprovemodelingoperationsandgeneratedocumentationwithiLogic.It'llevenit'llevenenableeasierdatamanagementandcollaborationbetweenInventorandVault.AndwithinVaultitself,we'relaunchingabrandnewagenticcapability. Imaginewantingtocreateanewproductthat'ssimilartowhatyou'vebuiltbefore.You'llbeabletofindandevaluateexistingdesignsusingAIandnaturallanguageintheassistant.Thishelpsyoumaximizethevalueofyourdatatomakebetterdecisions. Andthat'sreallythebiggerstoryhere.Turningyourdataintoanadvantageforyourorganization.Solet'stalkaboutdata.HowFusionandFusionManagewillunlockcapacitywiththedigitalthreadofdata. Toshowuswhatthislookslike,pleasewelcometothestagetwomoreofourFusionexperts.StephanieandMike. \[APPLAUSE, CHEERING\] STEPHANIE CANORA:Thanks,Jeff.Solet'sgetbacktothisroboticlawnmower.Todaywe'regoingtobuildthenextgeneration.Andit'sgoingtobebuiltforevenbiggerapplications.Thinkgolfcourses. SoI'llplaytheroleoftheengineeringmanager,andMikehereisourmechanicalengineer.Whenourteamstartsourday,westartwithFusion'sintegratedtaskmanagement.Sohere,whatyou'relookingatisnotonlyoneproject,butallofmytasksandthestatusofallofmyprojects. SoI'llgoaheadandI'llclickintothisparticularproject'sKanbanboard.Now,whatIdidn'tmentionisthatMikejuststartedlastweek.SoIthinkhe'sgoingtobeprettygreat,butlet'sputhimtothetest.I'mgoingtoassignhimatasktokickoffthisprojectwithournewagenticexperience. MIKE ALCAZAREN:Wow.Soonlymysecondweekin,andIalreadyhaveaKanbanboard.Thankfully,it'sfullyprioritized,soI'vegotthis.Igotaheadstartonthosetasks.Ijustuploadedtherequirementsdocument,andAutodeskassistant.Ithelpedmefindtheoptimalpartsandoptimalassembliestohelpmegetstarted. Whoa,itlookslikeitevenfoundanactivechangeorderonourchargingportduetoendoflife.Andit'slettingusthatweneedtoaddressourwatersealingapproachuptoIP66onourcameraassembly. SoI'monarollhere.Solet'sseeifIcanknockoutthesenexttwotasks.Thankfully,myclipboardisfullyloaded,soIcandropthepromptrightintoAssistant.Now,I'veaskedAssistanttofindareplacementforthischargingsocket.Iwanttomakesurethatthischargingsocketbothmatchesthepart'soriginalgeometry,andit'salreadyareleasepartwithinoursystem. Behindthescenes,Assistant,it'susinganindustryfoundationmodeltocombthroughyearsofsimilargeometryandyearsofsimilarmetadata.Oh,nice.Lookslikeourturfgrassdivisionhasareleasepartthat'saperfectmatchthatwecanuseinourdesign.I'llhaveAssistantreplacethat. Solet'sZoominherewhileAssistantworkstothechargingsocketthatwe'regoingtoreplace.ButI'malreadylovingthisnewagenticexperience.EventhoughI'mnewandfreshtothisproject,I'mabletogetrightuptospeed,findthatreplacementpart,andmakemeaningfulprogressagainstmytasklist. Oh,great.ItlookslikeassistanthasreplacedthechargingsocketintheexactcoordinateswithinourCADmodel,andupdatedthebillofmaterials.Awesome.That'sdefinitelygoingtosavemereworktimelateron.Nexttask.Ourrequirementsdocument,itcapturedfeedbackfromthefieldthatwehavetomakesurethesenewcommercialunitssurviveahosedownduringroutinemaintenance. I'veaskedAssistanttohelpuswiththatwaterprotectionstrategynext.Sowow,I'mjustblownawayattheprogresswewereabletomaketoday.EventhoughI'mcominginfreshandnewtothisproject,Iwasabletogetrightuptospeed,findthatreplacementpart,andmakesurewecanreplacethis.Great.Ithinkit'sStephanie'sturnforatasknow,soletmeassignherataskthroughassistanttoreviewthatchargingsocket.Backtoyou. STEPHANIE CANORA:SeewhatImean.He'snotonlycompletingtasks,butalreadyassigningmetasks.OK,sohere'smytasktoreviewthatwatersealingapproach,sothatIP66ismet.SowhatissoamazingaboutFusion'sintegratedtaskmanagementisthatprioritiesanddataareone.Soletmeshowyouwhatthatlookslike.Clickingintothisdesign,Inotonlyseeitstasks,Icanalsoviewthesubassembly.Icanseeotherrelateddata,seerecentcommentsandmore. Forthisparticulartask,Ineedtocheckacoupleofthingsinthebillofmaterial.SoI'mjustgoingtotakealook.We'vegotgasketandsealantadded.Great.Andthen,Iwanttocheckthevendorbecausewehavehadsomeproblems,butthisisourpreferredvendor.Great.OK. SolastthingIneedtodohereIwanttomakesureMikeknowsthatIcompletedmytask.SoI'llgoaheadandmarkthatdone.Sothatwasreallyfast.Whatdidwealljustsee?Whateveryouandyourteamdesignandbuild,Fusion'sthreadrunsrightthroughit.Itconnectsintenttorealdata,soyourrequirements,decisions,andchangesallcarryforward. InFusion,nothinggetsbuiltorboughttwice.SoMike,shouldwecreateataskforJefftocomebackouthere? MIKE ALCAZAREN:Definitely.Let'smakeitahardone. STEPHANIE CANORA:Ooh,maybestresstestingontheblades. MIKE ALCAZAREN:Oh,thatsoundslikeareallyhardone.Let'sabsolutelydothatone. STEPHANIE CANORA:OK. MIKE ALCAZAREN:Oh,yeah,stresstestingthoseblades.Putittothat. STEPHANIE CANORA:OK,IthinkImightdoaduedateoftoday.Whynot?Itdoesn'thaveanythingelsegoingon. MIKE ALCAZAREN:Increasethatpriority.IncreasedpriorityforJeff.Only,mediumshouldbehigh. STEPHANIE CANORA:OK.Oh,thereitis.OK,Jeff. JEFF KINDER:I'mcoming.

CIMdata · Oct 28, 2026

PLM Software · AI in Product Development

PLM professionals will convene for two days of collaborative insights into the opportunities and challenges of AI across the product lifecycle. ANN ARBOR, Michigan, USA & Stockholm, Sweden, October 28, 2026—The planning committee responsible for PLM Road Map & PDT Europe 2026 has announced that the upcoming PLM Road Map & PDT EMEA 2026 conference has reached maximum capacity and is officially sold out. Scheduled for 4-5 November 2026 at the Lindholmen Conference Centre in Gothenburg, Sweden, the event brings together senior executives, engineering leaders, and PLM practitioners from across Europe and around the globe. This year’s theme, AI in PLM: A Disruptive Opportunity and Challenge, Turning AI disruption into enterprise value: Strategic insights for the PLM professional, focuses on navigating disruption, strategic implementation, and AI governance within PLM, and has drawn unprecedented interest from across the industrial manufacturing ecosystem. “The rapid pace of technological change, particularly at the intersection of enterprise PLM, digital threads, and AI, has created a critical need for candid, peer-driven dialogue,” said Cheryl Peck, CIMdata’s Chief Marketing Officer. “Reaching full capacity before the conference opens underscores the PLM community’s vitality and the urgency of these topics. We are thrilled by the overwhelming response and look forward to delivering an impactful agenda.” “PLM continues to expand its reach, connecting an ever-growing number of people, processes, and functions across organizations. With the rapid emergence of AI in PLM, we now have an opportunity to rethink established ways of working and achieve levels of speed, insight, and efficiency that would have seemed unattainable just a few years ago. Yet, regardless of how technology evolves, people will remain at the heart of PLM,” said Håkan Kårdén, CEO of Håkan Kårdén AB and a member of the conference planning committee. “The fact that the conference is sold out is a clear reflection of the strong demand for these conversations and the continued importance of meeting face-to-face. We are delighted by the overwhelming interest and look forward to welcoming PLM professionals from across the industry for what promises to be a highly engaging event.” PLM Road Map & PDT EMEA 2026 features a curated lineup of keynote presentations, practitioner-led case studies, interactive panel sessions, and a Collaboration Café, where leading PLM solution and service providers showcase their cutting-edge technologies. Key topic areas for the two days include: • AI in Engineering & Manufacturing: Moving beyond experimentation to secure and govern enterprise value. • The Digital Thread & Digital Twins: Establishing end-to-end traceability across complex product architectures. • Open Collaboration & Standards: Enabling multi-enterprise data exchange using PDT best practices. With registration officially closed, we are preparing for an exciting year ahead and invite you to join us in 2027 as we bring the PLM community together in the Washington, D.C. area in spring and in Paris, France, in the fall. To learn more about attendance and sponsorship opportunities, contact CIMdata at This email address is being protected from spambots. You need JavaScript enabled to view it. .

theinterline.com · Oct 27, 2026

PLM Software · Industry Trends

AI-generated summary: PLM remains fashion’s most mature technology category, but The Interline argues that its expanding enterprise footprint and emerging AI capabilities are renewing its importance. Long embedded in major brands’ and retailers’ operations, PLM provides the product-data foundation for digital transformation. The article presents it as both an established operational backbone and a platform with substantial potential to generate additional value through broader connectivity and new ways of accessing information. PLM’s original promise was to create a single, durable, shareable product record covering style data, bills of materials, technical specifications, materials, colours, sizing, supplier scorecards and sampling workflows. Many large brands realised that vision through implementations that predate today’s dominant software-as-a-service and cloud-native models. Others have undertaken second or third PLM projects after earlier efforts fell short. The article acknowledges those disappointments but argues that companies’ continued commitment to the category demonstrates how difficult it is to operate without a single source of truth. Vendor claims illustrate PLM’s scale and widening scope. Bamboo Rose says its platform manages more than $1 trillion in retail goods annually, supporting planning, merchandising, design and development; its TotalPLM positioning also encompasses sourcing and supply chain activities. Centric Software advertises more than 13,000 brands using PLM as a foundation for enterprise ambitions, describing a “concept to commerce” reach. Its portfolio extends from core PLM to visual boards and AI-powered product experience management, or PXM. DeSL promotes a “concept to shelf” approach that replaces spreadsheets, emails and disconnected systems with centralised collaboration and decision-making, linking fashion-specific PLM with product information management, supplier management and colour workflows. The commercial case for these broader capabilities is reinforced by global conflict, changing consumer behaviour and volatile commodity prices. Research conducted by The Interline with Fashion By Informa identified profitability, risk mitigation and the ability to capture new market and margin opportunities as fashion professionals’ leading priorities. The article connects those priorities to PLM’s data, established practices and enterprise integrations. Decisions affecting margins and growth increasingly cross traditional system boundaries, making live product information relevant to early assortment planning and pricing as well as later channel allocation, content creation and consumer experiences. Advisory firm Kalypso is presented as supporting this broader role for PLM through services grounded in decades of implementation and digital-transformation experience. AI adds urgency to that expansion. While the article acknowledges that natural-language interfaces, MCP/API connectivity and agentic AI may not benefit every software category equally, it argues that PLM is a particularly strong candidate because it combines mission-critical information with consequential decisions across multiple functions. The Interline considers this an especially useful setting for a copilot, although the expected benefits remain an editorial assessment rather than demonstrated performance results. Adjacent providers also contribute: Made2Flow’s links to PLM allow design, development and sourcing users to reference and act on lifecycle impact data within relevant workflows. Early findings from The Interline’s 2026 AI survey suggest that fashion professionals see the most mature AI applications at the beginning and end of the product journey—in creative inspiration and design, and in content creation and marketing. The article identifies an opportunity between those endpoints, where decisions depend on supplier information, costs, calendars, compliance records and certificates. Its illustrative use case involves a non-traditional PLM user asking an integrated assistant which styles under development use fabric from a tariff-exposed supplier, then identifying tested, certified alternatives and assessing their effects on margins and schedules. This is presented as a grounded contemporary application, not a documented customer deployment. The article concludes that the central question for brands and retailers is no longer whether they need PLM, but which platforms offer suitable next-generation capabilities and connectivity across the full product lifecycle. Digital Product Passport regulations and difficult market conditions strengthen the case for accessible, consistent product information. For both first-time adopters and companies replacing legacy systems, the opportunity lies in extending a mature foundation rather than abandoning its original purpose.

nec.com · Oct 27, 2026

AI in Product Development

Breadcrumb navigation NEC contributes to AI powered Vaccine Design through the EU funded PREPAIR VAC Pandemic Preparedness Project Tokyo, Japan and Schiphol, Netherlands – October 26, 2026 – NEC Corporation (NEC; TSE: 6701) today announced its participation in PREPAIR VAC, a Horizon Europe–funded research project aimed at strengthening pandemic preparedness through the application of artificial intelligence (AI) in vaccine design. The grant has been awarded to NEC OncoImmunity AS (NOI)—a wholly owned subsidiary of NEC Bio within NEC Corporation—alongside several European partners comprising a research consortium. This four-year research grant beginning in September 2026, with a total budget of approximately €6.5M, aims to address major challenges in vaccine design in the context of pandemic preparedness, bringing together leading organizations across the vaccine development ecosystem. European partners from academia, industry, and public health have come together to establish a next generation vaccine development framework capable of responding more rapidly to emerging infectious diseases. Within the consortium, NOI, the primary initiator of the project, is responsible for AI powered antigen prediction and vaccine design, applying its cutting edge and advanced technologies to anticipate viral evolution and design broadly protective antigens. This approach is intended to support the development of broadly protective vaccine candidates and reduce the time required to progress from pathogen identification to vaccine design. Dr. Kaidre Bendjama, Chief Scientific Officer, NEC OncoImmunity, said: "PREPAIR VAC reflects the European Commission’s confidence in the role of AI driven design in strengthening European pandemic preparedness. Building on our experience in the field, NEC is applying AI technologies to create novel rapidly scalable vaccines that address current pathogen and host diversity while anticipating future mutations. The consortium brings together complementary expertise across the vaccine development lifecycle to generate a solid proof-of-concept package using preclinical and translational models." The project is coordinated by the European Vaccine Initiative (EVI) and includes partners specializing in manufacturing, formulation, preclinical validation, and ethical, legal, regulatory and societal aspects of vaccine innovation. In addition to scientific and technological development, PREPAIR VAC also addresses responsible use of AI, public trust, and regulatory considerations. About PREPAIR VAC PREPAIR VAC is a Horizon Europe–funded research project focused on the development of a rapid, AI driven vaccine design pipeline to improve preparedness for emerging infectious diseases. Other project partners include: NEVEZYNE SAS (France) Croda Denmark A/S (Denmark) Uppsala University (Sweden) Université Jean Monnet – Saint Étienne (France) Niedersächsisches Landesgesundheitsamt (Germany) Medizinische Hochschule Hannover (Germany) About HORIZON Europe Horizon Europe, the European Union’s €95.5 billion research and innovation programme for 2021–2027, is highly competitive, multi national projects addressing strategic challenges. The project was selected under a call focused on pandemic preparedness and next generation vaccine technologies, an area of significant EU investment following COVID 19. Horizon Europe funding is awarded through a rigorous evaluation process, with only a limited number of proposals receiving support. PREPAIR VAC forms part of the programme’s broader multi billion euro commitment to strengthening health resilience and accelerating innovation in vaccine development. The selection highlights the importance of AI driven approaches in enabling faster and more predictive responses to emerging infectious diseases. About NEC Corporation The NEC Group leverages technology to create social value and promote a more sustainable world where everyone has the chance to reach their full potential. NEC Corporation was established in 1899. Today, the NEC Group’s approximately 110,000 employees utilize world-leading AI, security, and communications technologies to solve the most pressing needs of customers and society. For more information, please visit https://www.nec.com and follow us on Instagram, Facebook, and LinkedIn. About NEC Bio NEC Bio is the biotechnology arm of NEC Corporation, headquartered in the Netherlands, and focused on leveraging state-of-the-art AI technologies to address the world's most pressing healthcare challenges. Leveraging cutting-edge science, data, and innovation, NEC Bio is dedicated to developing personalized therapies designed to transform patient outcomes and improve quality of life globally. With a growing international footprint, NEC Bio includes subsidiaries such as NEC OncoImmunity in Oslo, Norway, and NEC Bio Therapeutics in Mannheim, Germany—each contributing specialized expertise across immunotherapy, precision medicine, and translational research. Together, these entities form a collaborative ecosystem committed to accelerating innovation from discovery to patient impact. To learn more, visit www.nec-bio.com and follow us on LinkedIn for the latest updates. NEC is a registered trademark of NEC Corporation. All Rights Reserved. Other product or service marks mentioned herein are the trademarks of their respective owners. ©2026 NEC Corporation. Press "×" (Close) or Esc key Press Esc key for close

jamasoftware.com · Oct 27, 2026

Standards & Regulation

What Is IEC 62304? A Guide to Medical Device Software Follow a manual added link Follow a manual added link The Essential Guide to Requirements Management and Traceability Follow a manual added link The Essential Guide to Requirements Management and Traceability Chapters • 1. Requirements Management • Overview • 1 What is Requirements Management? A Complete Guide • 2 Why Do You Need Requirements Management? • 3 Four Stages of Requirements Management Processes • 4 Adopting Agile Requirements Management Tools • 5 Status Request Changes • 6 Conquering the 5 Biggest Challenges of Requirements Management • 7 Three Reasons You Need a Requirements Management Solution • 8 Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them • 9 What Is a Requirements Management Plan? A Practical Guide • 10 Enterprise Requirements Management: Keeping Traceability Current • 2. Writing Requirements • Overview • 1 Functional Requirements Examples and Templates • 2 What Is a Product Requirements Document? A Complete PRD Guide • 3 What Is a User Requirement Specification (URS)? How to Write and Manage One • 4 Identifying and Measuring Requirements Quality • 5 How to Write a System Requirements Specification (SRS) Document • 6 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence • 7 Adopting the EARS Notation to Improve Requirements Engineering • 8 What Is a Compliance Risk Assessment? Steps, Framework, and Examples • 9 Jama Connect Advisor™ • 10 How to Write an Effective Product Requirements Document (PRD) • 11 Functional vs. Non-Functional Requirements • 12 What Are Nonfunctional Requirements and How Do They Impact Product Development? • 13 What Is a Software Design Specification? Key Components + Template • 14 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS) • 15 8 Do’s and Don’ts for Writing Requirements • 16 Project Requirements: Types, Process, and Best Practices • 17 INCOSE Guide to Writing Requirements • 18 How to Write Technical Requirements That Survive Verification • 19 Types of Requirements in Engineering: A Complete Guide • 3. Requirements Gathering and Management Processes • Overview • 1 Requirements Engineering • 2 Requirements Analysis • 3 A Guide to Requirements Elicitation for Product Teams • 4 Requirements Gathering Techniques for Agile Product Teams • 5 Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices • 6 Defining and Implementing a Requirements Baseline • 7 Managing Project Scope — Why It Matters and Best Practices • 8 Requirements Decomposition and How AI Supports It • 9 How Long Do Requirements Take? • 10 How to Reuse Requirements Across Multiple Products • 11 Requirements Prioritization Techniques: 7 Methods for Engineers • 12 How to Run a Requirements Gathering Workshop • 4. Requirements Traceability • Overview • 1 What Is Traceability? A Guide for Regulated Product Teams • 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development • 3 Bidirectional Traceability: What It Is and How to Implement It • 4 Change Impact Analysis (CIA): A Short Guide for Effective Implementation • 5 What is Engineering Change Management (ECM)? A Complete Guide • 6 What is Meant by Version Control? • 7 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency • 8 The Role of a Data Thread in Product and Software Development • 9 What is a Traceability Matrix? A Guide to Requirements Traceability • 10 How to Create and Use a Requirements Traceability Matrix (RTM) • 11 Requirements Traceability Matrix Pros and Cons: A Practical Guide • 12 Live Traceability vs. After-the-Fact Traceability • 13 Requirements Traceability, What Are You Missing? • 14 Requirements Traceability: Links in the Chain • 15 What Are the Benefits of End-to-End Traceability During Product Development? • 16 Requirements Volatility: 7 Essential Management Strategies • 17 FAQs About Requirements Traceability • 18 What Is AI Traceability? How to Implement It • 19 Product Traceability for Regulated Industries: A Complete Guide to Audit-Ready Compliance • 20 What Is the Traceability Information Model? • 21 Supply Chain Traceability: What to Send Suppliers and What to Get Back • 22 What Is an Engineering Change Order (ECO)? • 5. Solutions for Capturing and Tracking Requirements • Overview • 1 Selecting the Right Requirements Management Tools • 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn • 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development • 4 Can You Track Requirements in Excel? • 5 What Is Application Lifecycle Management (ALM)? • 6 Requirements Management Tools Jira • 7 Requirements Management Checklist: Selecting the Right Tool • 6. Requirements Validation and Verification • Overview • 1 Requirements Verification and Validation for Product Teams • 2 Best Practices for Verification and Validation in Product Development • 3 Requirement Validation and Traceability Explained • 4 What Is System Integration Testing (SIT)? A Complete Guide • 7. Meeting Regulatory Compliance and Industry Standards • Overview • 1 Understanding ISO Standards • 2 Understanding ISO/IEC 27001: A Guide to Information Security Management • 3 What is DevSecOps? A Guide to Building Secure Software • 4 Compliance Management • 5 What Is Functional Safety (FuSa)? Standards, Lifecycle, and Where Programs Fail • 6 Failure Mode and Effects Analysis (FMEA) Explained • 7 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide • 8 What Is IEC 62443? A Complete Guide to Industrial Cybersecurity • 9 DFARS Compliance: A Guide for Defense Contractors • 10 CMMC vs FedRAMP: What’s Different and Which One Applies to You • 11 Automotive SPICE (ASPICE) 4.0: A Complete Guide • 12 Restriction of Hazardous Substances (RoHS) Compliance Guide • 13 MISRA C and MISRA C++ Explained: Rules for Safer Embedded Code • 14 REACH Compliance for Product Engineering Teams • 15 Radio Equipment Directive (RED) Cybersecurity Requirements • 16 What Is a Software Bill of Materials? • 8. Systems Engineering • Overview • 1 What is Systems Engineering? A Guide for Modern Engineering Teams • 2 How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation • 3 The Systems Engineering Body of Knowledge (SEBoK) • 4 What Is MBSE? Model-Based Systems Engineering Explained • 5 Digital Engineering Between Government and Contractors • 6 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems • 7 What Is Bill of Materials (BOM) Management? A Guide to Controlling Product Data • 9. Automotive Development • Overview • 1 Understanding IATF 16949: A Quick Guide to Automotive Quality Management • 2 What Is ISO 21434? Automotive Cybersecurity Engineering Explained • 3 What Is an Automotive Safety Integrity Level (ASIL)? • 4 What Is SOTIF? A Guide to ISO 21448 for ADAS Safety • 10. Medical Device & Life Sciences Development • Overview • 1 The Importance of Benefit-Risk Analysis in Medical Device Development • 2 Software as a Medical Device: Revolutionizing Healthcare • 3 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry • 4 What’s a Design History File, and How Are DHFs Used by Product Teams? • 5 What Is ISO 13485? A Guide to Medical Device Quality Management Systems • 6 What Is IEC 62304? A Guide to Medical Device Software • 7 What Is a Device Master Record (DMR)? Definition and FDA Requirements • 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know • 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT) • 10 What Is General Safety and Performance Requirements (GSPR)? What You Need To Know • 11 What Is IEC 62366? Usability Engineering for Medical Devices • 12 What Is the Quality Management System Regulation (QMSR)? • 13 510(k) vs PMA: Differences in FDA Device Approval and Clearance • 14 EU MDR Compliance Requirements and Timeline • 15 Essential Performance Requirements and How to Identify Them • 16 DHF vs DMR vs DHR: What Changed Under the FDA QMSR • 17 Computer Software Assurance for Production and Quality Systems • 18 IVDR Compliance: What Manufacturers Need to Know • 19 IVDR Compliance: What Manufacturers Need to Know (copy) • 20 IEC 60601-1 Guide for Medical Devices • 21 A Guide to Medical Device Requirements Management • 11. Aerospace & Defense Development • Overview • 1 What is ITAR Compliance? What Engineering Teams Need to Know • 2 What Is DO-278A? A Guide for Compliance Teams • 3 ARP4754B Explained: Changes, Recognition, and Compliance • 4 What Is a Safety Integrity Level (SIL)? How to Calculate and Apply It • 5 A Guide to Aerospace Requirements Management • 6 What Is ARP4754A? A Complete Guide to Civil Aircraft and Systems Development Assurance • 7 Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace • 8 What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance • 9 What Is DO-178C? A Guide to Airborne Software Certification • 12. Architecture, Engineering, and Construction (AEC industry) Development • Overview • 1 What is the AEC Industry? • 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy • Overview • 1 What Is IEC 61508? A Guide to the Functional Safety Standard • 2 Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector • 3 IEC 62061 – Functional Safety for Machinery Systems • 4 ISO 10218: Ensuring Safety in Industrial Robotics • 14. Semiconductor Development • Overview • 1 Why Chiplets Are Changing the Game in Tech Innovation • 2 Integrating Digital Engineering and the Digital Thread for Semiconductor Design • 15. AI in Product Development • Overview • 1 What Is AI in Product Development? A Complete 2026 Guide • 2 AI Test Case Generation: A Complete Guide for Regulated QA Teams • 3 Using AI to Write Software Requirements: What Works and What Doesn’t • 4 What Is the Model Context Protocol (MCP) for Requirements Management? • 5 AI for Systems Engineering: Benefits, Risks, and How to Start • 6 How to Automate Requirements Management • 16. Risk Management • Overview • 1 What Are Failure Modes? Types, Examples, and How to Identify Them • 2 What Is Software Risk Management? • 3 What Is a Risk Assessment Matrix? How to Build and Use One • 4 Types of FMEA: Definitions, Differences, and When to Use Each • 5 DFMEA vs PFMEA: Scope, Timing, and the Handoff Between Them • 17. Product Development Terms and Definitions • Overview • 1 Concurrent Engineering: Benefits, Challenges, and Best Practices • 2 eBOM vs mBOM: Differences and When Each Matters Chapter 10: What Is IEC 62304? A Guide to Medical Device Software Chapters • 1. Requirements Management • Overview • 1 What is Requirements Management? A Complete Guide • 2 Why Do You Need Requirements Management? • 3 Four Stages of Requirements Management Processes • 4 Adopting Agile Requirements Management Tools • 5 Status Request Changes • 6 Conquering the 5 Biggest Challenges of Requirements Management • 7 Three Reasons You Need a Requirements Management Solution • 8 Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them • 9 What Is a Requirements Management Plan? A Practical Guide • 10 Enterprise Requirements Management: Keeping Traceability Current • 2. Writing Requirements • Overview • 1 Functional Requirements Examples and Templates • 2 What Is a Product Requirements Document? A Complete PRD Guide • 3 What Is a User Requirement Specification (URS)? How to Write and Manage One • 4 Identifying and Measuring Requirements Quality • 5 How to Write a System Requirements Specification (SRS) Document • 6 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence • 7 Adopting the EARS Notation to Improve Requirements Engineering • 8 What Is a Compliance Risk Assessment? Steps, Framework, and Examples • 9 Jama Connect Advisor™ • 10 How to Write an Effective Product Requirements Document (PRD) • 11 Functional vs. Non-Functional Requirements • 12 What Are Nonfunctional Requirements and How Do They Impact Product Development? • 13 What Is a Software Design Specification? Key Components + Template • 14 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS) • 15 8 Do’s and Don’ts for Writing Requirements • 16 Project Requirements: Types, Process, and Best Practices • 17 INCOSE Guide to Writing Requirements • 18 How to Write Technical Requirements That Survive Verification • 19 Types of Requirements in Engineering: A Complete Guide • 3. Requirements Gathering and Management Processes • Overview • 1 Requirements Engineering • 2 Requirements Analysis • 3 A Guide to Requirements Elicitation for Product Teams • 4 Requirements Gathering Techniques for Agile Product Teams • 5 Requirements Gathering in Software Engineering: Process, Techniques, and Best Practices • 6 Defining and Implementing a Requirements Baseline • 7 Managing Project Scope — Why It Matters and Best Practices • 8 Requirements Decomposition and How AI Supports It • 9 How Long Do Requirements Take? • 10 How to Reuse Requirements Across Multiple Products • 11 Requirements Prioritization Techniques: 7 Methods for Engineers • 12 How to Run a Requirements Gathering Workshop • 4. Requirements Traceability • Overview • 1 What Is Traceability? A Guide for Regulated Product Teams • 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development • 3 Bidirectional Traceability: What It Is and How to Implement It • 4 Change Impact Analysis (CIA): A Short Guide for Effective Implementation • 5 What is Engineering Change Management (ECM)? A Complete Guide • 6 What is Meant by Version Control? • 7 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency • 8 The Role of a Data Thread in Product and Software Development • 9 What is a Traceability Matrix? A Guide to Requirements Traceability • 10 How to Create and Use a Requirements Traceability Matrix (RTM) • 11 Requirements Traceability Matrix Pros and Cons: A Practical Guide • 12 Live Traceability vs. After-the-Fact Traceability • 13 Requirements Traceability, What Are You Missing? • 14 Requirements Traceability: Links in the Chain • 15 What Are the Benefits of End-to-End Traceability During Product Development? • 16 Requirements Volatility: 7 Essential Management Strategies • 17 FAQs About Requirements Traceability • 18 What Is AI Traceability? How to Implement It • 19 Product Traceability for Regulated Industries: A Complete Guide to Audit-Ready Compliance • 20 What Is the Traceability Information Model? • 21 Supply Chain Traceability: What to Send Suppliers and What to Get Back • 22 What Is an Engineering Change Order (ECO)? • 5. Solutions for Capturing and Tracking Requirements • Overview • 1 Selecting the Right Requirements Management Tools • 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn • 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development • 4 Can You Track Requirements in Excel? • 5 What Is Application Lifecycle Management (ALM)? • 6 Requirements Management Tools Jira • 7 Requirements Management Checklist: Selecting the Right Tool • 6. Requirements Validation and Verification • Overview • 1 Requirements Verification and Validation for Product Teams • 2 Best Practices for Verification and Validation in Product Development • 3 Requirement Validation and Traceability Explained • 4 What Is System Integration Testing (SIT)? A Complete Guide • 7. Meeting Regulatory Compliance and Industry Standards • Overview • 1 Understanding ISO Standards • 2 Understanding ISO/IEC 27001: A Guide to Information Security Management • 3 What is DevSecOps? A Guide to Building Secure Software • 4 Compliance Management • 5 What Is Functional Safety (FuSa)? Standards, Lifecycle, and Where Programs Fail • 6 Failure Mode and Effects Analysis (FMEA) Explained • 7 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide • 8 What Is IEC 62443? A Complete Guide to Industrial Cybersecurity • 9 DFARS Compliance: A Guide for Defense Contractors • 10 CMMC vs FedRAMP: What’s Different and Which One Applies to You • 11 Automotive SPICE (ASPICE) 4.0: A Complete Guide • 12 Restriction of Hazardous Substances (RoHS) Compliance Guide • 13 MISRA C and MISRA C++ Explained: Rules for Safer Embedded Code • 14 REACH Compliance for Product Engineering Teams • 15 Radio Equipment Directive (RED) Cybersecurity Requirements • 16 What Is a Software Bill of Materials? • 8. Systems Engineering • Overview • 1 What is Systems Engineering? A Guide for Modern Engineering Teams • 2 How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation • 3 The Systems Engineering Body of Knowledge (SEBoK) • 4 What Is MBSE? Model-Based Systems Engineering Explained • 5 Digital Engineering Between Government and Contractors • 6 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems • 7 What Is Bill of Materials (BOM) Management? A Guide to Controlling Product Data • 9. Automotive Development • Overview • 1 Understanding IATF 16949: A Quick Guide to Automotive Quality Management • 2 What Is ISO 21434? Automotive Cybersecurity Engineering Explained • 3 What Is an Automotive Safety Integrity Level (ASIL)? • 4 What Is SOTIF? A Guide to ISO 21448 for ADAS Safety • 10. Medical Device & Life Sciences Development • Overview • 1 The Importance of Benefit-Risk Analysis in Medical Device Development • 2 Software as a Medical Device: Revolutionizing Healthcare • 3 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry • 4 What’s a Design History File, and How Are DHFs Used by Product Teams? • 5 What Is ISO 13485? A Guide to Medical Device Quality Management Systems • 6 What Is IEC 62304? A Guide to Medical Device Software • 7 What Is a Device Master Record (DMR)? Definition and FDA Requirements • 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know • 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT) • 10 What Is General Safety and Performance Requirements (GSPR)? What You Need To Know • 11 What Is IEC 62366? Usability Engineering for Medical Devices • 12 What Is the Quality Management System Regulation (QMSR)? • 13 510(k) vs PMA: Differences in FDA Device Approval and Clearance • 14 EU MDR Compliance Requirements and Timeline • 15 Essential Performance Requirements and How to Identify Them • 16 DHF vs DMR vs DHR: What Changed Under the FDA QMSR • 17 Computer Software Assurance for Production and Quality Systems • 18 IVDR Compliance: What Manufacturers Need to Know • 19 IVDR Compliance: What Manufacturers Need to Know (copy) • 20 IEC 60601-1 Guide for Medical Devices • 21 A Guide to Medical Device Requirements Management • 11. Aerospace & Defense Development • Overview • 1 What is ITAR Compliance? What Engineering Teams Need to Know • 2 What Is DO-278A? A Guide for Compliance Teams • 3 ARP4754B Explained: Changes, Recognition, and Compliance • 4 What Is a Safety Integrity Level (SIL)? How to Calculate and Apply It • 5 A Guide to Aerospace Requirements Management • 6 What Is ARP4754A? A Complete Guide to Civil Aircraft and Systems Development Assurance • 7 Understanding ARP4761A: Guidelines for System Safety Assessment in Aerospace • 8 What Is DO-254? A Complete Guide to Airborne Hardware Design Assurance • 9 What Is DO-178C? A Guide to Airborne Software Certification • 12. Architecture, Engineering, and Construction (AEC industry) Development • Overview • 1 What is the AEC Industry? • 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy • Overview • 1 What Is IEC 61508? A Guide to the Functional Safety Standard • 2 Understanding ISO 13849: The Foundation of Functional Safety in the Machinery Sector • 3 IEC 62061 – Functional Safety for Machinery Systems • 4 ISO 10218: Ensuring Safety in Industrial Robotics • 14. Semiconductor Development • Overview • 1 Why Chiplets Are Changing the Game in Tech Innovation • 2 Integrating Digital Engineering and the Digital Thread for Semiconductor Design • 15. AI in Product Development • Overview • 1 What Is AI in Product Development? A Complete 2026 Guide • 2 AI Test Case Generation: A Complete Guide for Regulated QA Teams • 3 Using AI to Write Software Requirements: What Works and What Doesn’t • 4 What Is the Model Context Protocol (MCP) for Requirements Management? • 5 AI for Systems Engineering: Benefits, Risks, and How to Start • 6 How to Automate Requirements Management • 16. Risk Management • Overview • 1 What Are Failure Modes? Types, Examples, and How to Identify Them • 2 What Is Software Risk Management? • 3 What Is a Risk Assessment Matrix? How to Build and Use One • 4 Types of FMEA: Definitions, Differences, and When to Use Each • 5 DFMEA vs PFMEA: Scope, Timing, and the Handoff Between Them • 17. Product Development Terms and Definitions • Overview • 1 Concurrent Engineering: Benefits, Challenges, and Best Practices • 2 eBOM vs mBOM: Differences and When Each Matters What Is IEC 62304? A Guide to Medical Device Software IEC 62304 is the international standard for developing and maintaining medical device software, whether the software is a medical device on its own or built into one. Every software system it covers gets a safety class of A, B or C, based on the worst-case harm the software could contribute to, and that class decides how much planning, design, testing and documentation you have to produce. FDA recognizes the current edition, so a 510(k) sponsor can cite it in a submission. FDA submissions should also show traceability from requirements to verification and risk controls. The sections below explain what each safety class requires, how risk controls trace to their verification, and how Software of Unknown Provenance (SOUP), code you use but didn’t develop for the device, is controlled at each class. What Is IEC 62304? The standard sets life cycle requirements for software that is itself a medical device and for software embedded in or integral to one. Validation and final release of the device are outside the standard’s scope, even when the device is entirely software, and the standard prescribes no life cycle model. Before any lifecycle work, a manufacturer needs a quality management system that satisfies ISO 13485. A risk management process that complies with ISO 14971 must also be in place, along with a safety class of A, B or C for each software system. Clauses 5 through 9 define development, maintenance, risk management, configuration management and problem resolution processes. The edition in force is the consolidated Edition 1.1, published on 26 June 2015. Edition 1.1 combines the original IEC 62304:2006 with Amendment 1:2015. FDA lists the consolidated Edition 1.1 as recognized consensus standard 13-79 with complete recognition. A 510(k) sponsor can therefore cite it in a submission. In the EU, notified bodies expect software documentation in technical files for the Medical Device Regulation (MDR) to follow EN 62304 and scale with the safety class, according to the notified-body association Team-NB. A technical file should cite EN 62304 as a benchmark, and claim presumption of conformity only once the Commission’s harmonized standards list for the MDR names it. Software Safety Classes Set the Depth of Evidence The safety class sets how much lifecycle evidence IEC 62304 requires, through the activities Table A.1 assigns to each class. Under Clause 4.3, each software system gets one of three safety classes, based on the worst-case harm it can contribute to after external risk controls: • Class A: The software either cannot contribute to a hazardous situation or has acceptable risk after external controls. • Class B: The software can contribute to a hazardous situation involving non-serious harm. • Class C: The software can contribute to death or serious injury. Unclassified software defaults to Class C, and the highest class of any component sets the class of the whole system. Under Amendment 1, classification assumes that software will fail to behave as specified. Severity and risk controls external to the software system determine the class, and reliability arguments, coverage figures and field history have no effect on it. | Activity | Clause | Classes it applies to | | Software development planning | 5.1 | A, B, C (several planning items B and C only, one C only) | | Software requirements analysis | 5.2 | A, B, C (one item B and C only) | | Software architectural design | 5.3 | B, C (one item C only) | | Software detailed design | 5.4 | C (one item B and C) | | Software unit implementation | 5.5 | A, B, C | | Software unit verification | 5.5 | B, C, with added acceptance criteria at C | | Software integration and integration testing | 5.6 | B, C | | Software system testing | 5.7 | A, B, C | | Software release | 5.8 | A, B, C | | Configuration management and problem resolution | 8, 9 | A, B, C | Table A.1 shows that Class A still requires planning, unit implementation, system testing, configuration management and problem resolution records. Class C differs from Class B chiefly in detailed design and in the additional unit acceptance criteria it requires. Code-based (white-box) testing happens primarily at unit level, according to FDA’s software validation guidance, so system tests alone don’t provide code-based coverage. The IEC 62304 Software Development Lifecycle and the Records It Leaves IEC 62304’s development process runs from planning to release, and each stage produces a record an auditor or FDA reviewer can request. The safety class decides which records exist, and FDA’s Documentation Level, Basic or Enhanced, affects how much of them goes into a submission. Planning, Requirements and Release Apply at Every Class Planning, requirements analysis and release records are required at every class, and Class B and C add items to the plan and the requirements. The software development plan names tools, methods and coding guidelines, and for Class B and C it covers how known defects are published. Where integration and system testing are combined, the plan must say so. Teams document requirements at every class, including information technology (IT) security, networking and user interface requirements. Requirements that implement risk controls belong in the Software Requirements Specification (SRS). Each should translate readily into a verification acceptance criterion, which is the link an auditor follows from the risk file to the test record. Release documentation identifies the version under application, and notified bodies expect a list of known residual anomalies with a justification for releasing with each. A technical file should include a clearly identified safety classification with its justification, plus a traceability matrix linking requirements to protocols, reports and test data, according to Team-NB. Architecture, Design and Verification Scale With Class B and C Architecture is required for Class B and C software and identifies software items and units, specifies interfaces, and documents the requirements and prerequisites for each SOUP component. The architecture is also an input to the software risk analysis. Unit verification applies at Class B and C, and Class C adds acceptance criteria such as event sequences, fault handling, memory management and boundary conditions. Integration testing exercises data and control transfer across architecture interfaces. Together with unit verification, it shows whether lower-level and interface behavior support the system requirements. Design and Development Requirements and the Submission Trace Under the QMSR Under the Quality Management System Regulation (QMSR), § 820.10(c) requires manufacturers of class II, class III and certain class I devices, including those automated with computer software, to comply with the design and development requirements of ISO 13485. ISO 13485 sets those requirements out in Clause 7.3 and its subclauses. The QMSR has been in effect since 2 February 2026. FDA recommends tracing each identified hazard to its verified risk controls, from an SRS requirement and its tests to a user manual or training identifier. When one hazard traces to several requirements and tests, a separate document can connect the SRS, design specification, testing and identified hazards. FDA sets an Enhanced Documentation Level where failure or a flaw of any device software function could present a hazardous situation with probable risk of death or serious injury, assessed before risk controls. Basic Documentation applies when Enhanced Documentation is not appropriate, although FDA also recommends Enhanced Documentation for certain device categories, including some blood-related devices, Class III devices, and device constituent parts of combination products. FDA sets one Documentation Level for the device as a whole, while IEC 62304 classifies each software system and its items, so the two schemes don’t map one to one. A sponsor can substitute a declaration of conformity to the recognized IEC 62304 for applicable development, maintenance and configuration management documentation. Learn About the QMSR Software Risk Management Under Clause 7 and ISO 14971 Software risk management under Clause 7 starts from hazardous situations already identified in the ISO 14971 system analysis. The team identifies which software items could contribute to each situation and records their potential causes, such as SOUP failures. Severity is taken from the system risk file, and the analysis works at least at software-item level. For every documented potential cause, you define, document, implement and verify a risk control measure, often as a new requirement in the SRS. FDA ranks risk control options from design changes, through protective measures, to information for safety, in its premarket software guidance. Verification also checks whether a measure creates a new hazardous situation. For Class B and C software, the manufacturer documents four traceability links that connect system risk analysis to software implementation and verification, and the record should make each one explicit: • Hazardous situation to software item: The system risk file names the item whose failure could contribute to the situation. • Software item to software cause: The record explains how that item fails, including a SOUP failure or unexpected result. • Software cause to risk control measure: The record links the control, usually a requirement, that addresses that cause. • Risk control measure to its verification: The record cites the test or review showing the control was implemented and is effective. At every class, Clause 7.4 requires a change analysis that looks for new causes and risk controls, including for SOUP changes. Class B and C must also analyze the impact on existing controls and act on the result. After release, the change is also covered by ISO 14971 post-production activities. \[MID-PAGE CTA: Promote the datasheet “FMEA Framework for Medical Device Development” \| https://www.jamasoftware.com/datasheet/jama-software-fmea-medical-device-development-datasheet/. Button text: Get the FMEA Datasheet. Note for publishing: RM Hub, copy the button HTML from the reference template\] Software Maintenance Under Clause 6 Clause 6 of IEC 62304 is the process for changing medical device software after release. Its three activities are establishing a software maintenance plan, problem and modification analysis, and modification implementation. Every requirement in the clause applies at Class A, B and C, according to Table A.1, so you need a maintenance plan and change records even for Class A software. Problem and modification analysis starts with monitoring feedback on software released for intended use. Each problem report is then evaluated for its effect on safety and for whether the software needs to change, using the software problem resolution process. A problem can also show that a software system or software item was placed in the wrong safety class. Each change request gets an impact analysis of its effect on your company, the released software and the systems it interfaces with, and each one needs approval. Approved changes are also communicated to affected users and regulatory authorities when required. During modification implementation, you identify which Clause 5 activities the modification requires you to repeat, and you perform them. The modified software is then released through the standard’s software release activity. Risk management of software changes has its own requirements, set out in the risk management section above. Configuration management records link each change request to its relevant problem report and to its approval at every class, and the late-change walk-through below applies them to a Class C program. An auditor checking maintenance can ask for the maintenance plan, the evaluated problem reports and the linked change records. Configuration Management and Problem Resolution Through a Late Change Every late change passes through configuration management and problem resolution, which apply at every class. Configuration management identifies SOUP and every other configuration item. A controlled item changes only through an approved change request, and the team verifies, traces and logs the change in status accounting. Problem resolution produces a problem report, investigates it, advises relevant parties and evaluates trends. A late change in a Class C program means re-checking the requirement that changed, the risk control that depended on it, and every verification record built on either. For that change, an auditor expects an approved change request and a cause investigation covering process, methods, tools or code. The record then shows updated requirements and architecture, plus class-scaled regression across unit, integration and system tests through release. Archived test cases and prior verification and validation (V&V) results let you scope regression after a change. Xoran Technologies left unclear whether its regression analysis had determined which unit, integration and system-level tests to re-run after software changes, or whether code coverage matched the risk, FDA wrote in a December 2024 warning letter. Between 1992 and 1998, 192 of 242 software-related recalls came from defects introduced by changes made after the software’s initial production and distribution, according to FDA’s General Principles of Software Validation. ISO 13485 Clause 7.3.9 requires teams to review, verify or validate design changes as appropriate and approve them. New app treatments that ZIIP, Inc. added in October 2025 lacked documentation or supporting V&V even though the company’s own procedures required review for repeat V&V, FDA found in a 2026 warning letter. Pensar Medical communicated a hold on one firmware change order only verbally, with no nonconformance report, and had submitted no documented formal risk assessment for a later firmware update, the agency found that year. Controlling SOUP by Safety Class SOUP control scales by class, with identification at every class and specification and anomaly evaluation added at Class B and C. Software qualifies as SOUP when it was already developed and generally available but wasn’t developed for the device, or when it was previously developed with inadequate development records. The medical device software system as a whole cannot be claimed as SOUP, although individual software items, including previously developed internal software lacking adequate development records, may qualify as SOUP. FDA’s off-the-shelf (OTS) software guidance covers the same ground without using the term SOUP. Each SOUP item’s configuration record lists the title, manufacturer and a unique designator such as a version, release date, patch number or upgrade designation. The maintenance plan explains how the team evaluates upgrades, patches and obsolescence. Section 524B(b)(3) of the Federal Food, Drug, and Cosmetic Act requires cyber device manufacturers to provide a Software Bill of Materials (SBOM) covering commercial, open-source and off-the-shelf components. FDA asks for it in a machine-readable format in its cybersecurity guidance. An SBOM of that kind covers SOUP identification, the part of SOUP control owed at every class. At Class B and C, the architecture states each item’s functional and performance requirements for its intended use, plus the hardware and software it needs. Verification confirms that the item works as specified on that hardware and software. Where SOUP failure could cause a hazardous situation, you evaluate the supplier’s published anomaly list for the version in use and record the potential causes in the risk management file. A record that names the sources searched, the search date, the anomalies found and the hazard analysis of each lets an auditor see that the evaluation was done. Where IEC 62304 Edition 2 Stands Edition 2 isn’t published yet, and the IEC lists it as in development. Publication is forecast for October 2028, a forecast that teams shouldn’t plan around. Its second Committee Draft (CD) 62A/1761/CD circulated on 7 August 2026 with comments closing on 27 November 2026, according to IEC Technical Committee 62, Subcommittee 62A. The draft extends its scope to all health software, including software as a medical device (SaMD) and software with AI or machine learning (ML) algorithms, and is retitled to match. Conformity under the draft is assessed against what it calls a software process rigour level. Reviewers apply Edition 1.1 and its Table A.1 until the new edition is published. How Jama Connect Supports IEC 62304 Jama Connect®, a web-based requirements management and traceability platform, can hold the SOUP list and its anomaly evaluations in custom item types, with a picklist field recording each software item’s safety class. Administrators can configure those item types and the pre-built medical device Traceability Information Model (TIM) to include SOUP records, configuration items and problem reports with required links, as the TIM already does for requirements and tests. When a requirement changes late in a Class B or C program, suspect links flag every linked test and risk item for review. Coverage gap detection identifies requirements without linked verification and any other missing link the TIM requires, such as a risk control. For review and release evidence, Review Center records approvals with electronic signatures aligned to FDA’s 21 Code of Federal Regulations (CFR) Part 11. The medical device frameworks ship with pre-built risk analysis reports, so teams can analyze risk without first building report templates. Export templates aligned to regulatory submission requirements produce traceability matrices and risk management files from the linked records, which teams may organize as a Design History File (DHF) in the industry sense. Medimaps cut FDA submission preparation from over a week to a few hours.

jamasoftware.com · Oct 27, 2026

Customer Stories · Digital Thread & Digital Twin

Jama Software Announces Renesas Selects Jama Connect® to Transform Engineering October 20, 2026 / by Decoteau Wilkerson BOSTON, MA. – October 20, 2026 – Jama Software , a leading provider of intelligent engineering management solutions, today announced that Renesas Electronics Corporation, a premier supplier of advanced semiconductor solutions, has selected Jama Connect to support engineering process improvement initiatives and AI-enabled development activities across its semiconductor engineering organization. As organizations evaluate opportunities to leverage artificial intelligence throughout the semiconductor product development processes, maintaining a reliable and connected foundation for requirements management, traceability, and collaboration across hardware, software, systems engineering, quality, and product teams has become increasingly important. Renesas selected Jama Connect based on its ability to support multidisciplinary engineering teams with a flexible information model, end-to-end traceability, and collaborative development processes. Jama Connect will support Renesas’ efforts to enhance visibility across engineering activities, improve collaboration among teams, and strengthen requirements management practices as semiconductor product development complexity continues to increase. “As we continue to explore opportunities to leverage AI within our semiconductor product development processes, maintaining a strong foundation for requirements management, traceability, and engineering collaboration remains an important objective,” said Mohammed Dogar, Vice President, Business Acceleration, Renesas Electronics Corporation. “Jama Connect aligns with these objectives and will support our ongoing efforts to enhance engineering efficiency and consistency across teams.” “Semiconductor companies are under enormous pressure to manage rising product complexity while accelerating innovation,” said Neil Stroud, General Manager, Semiconductor at Jama Software. “By choosing Jama Connect as its engineering product context platform, Renesas is creating a trusted, traceable foundation for AI – connecting requirements, architecture, risks, decisions, and verification across hardware and software teams. That context will enable engineers to use AI with greater confidence, make better decisions, reduce rework, and bring complex semiconductor products to market faster.” Through the adoption of Jama Connect, Renesas intends to support: • Improved requirements management and lifecycle traceability • Enhanced collaboration across engineering disciplines • Greater visibility and consistency of engineering information • More efficient onboarding and knowledge sharing • Scalable development processes to support future innovation and growth The collaboration reflects a shared focus on engineering excellence, quality, and continuous improvement as organizations seek to modernize development processes and support evolving business and technology requirements. About Jama Software Jama Software is focused on maximizing product velocity for regulated multidisciplinary engineering organizations. Jama Connect delivers the ROI from AI-Driven Development by optimizing product velocity, inference quality and token efficiency while ensuring AI and regulatory compliance. Our rapidly growing customer base spans aerospace & defense, automotive, medtech & life sciences, semiconductor, industrial manufacturing, consumer electronics, infrastructure, robotics and energy. For more information, please visit https://www.jamasoftware.com.