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ISO 13485 is the international standard for quality management systems in the medical device industry. It defines the requirements for designing, manufacturing, and servicing medical devices in a way that consistently meets customer and regulatory expectations. Most regulatory bodies around the world recognize ISO 13485, and as of February 2026, the FDA’s new QMSR incorporates it by reference as the foundation for U.S. device quality requirements.

21 CFR 820 was the FDA’s Quality System Regulation governing how medical devices are designed and manufactured in the United States, covering areas such as design controls, production processes, corrective actions, and documentation. As of February 2, 2026, the FDA updated this framework through the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference while retaining and clarifying FDA-specific requirements such as medical device reporting, labeling, and UDI compliance.

The FDA QMSR, effective February 2, 2026, incorporates ISO 13485:2016 by reference and retains FDA-specific requirements for records, labeling, UDI, and medical device reporting. If your QMS already aligns with ISO 13485, the transition is more straightforward but still requires mapping to the updated 21 CFR 820 structure and addressing FDA-specific expectations. If it was built around the legacy 21 CFR 820 framework, you’ll need more substantial updates to align your processes, documentation, and terminology with the ISO-based QMSR framework.

Every user need should link forward to design inputs, outputs, and verification/validation evidence, and you need to traverse that chain in both directions on demand. When those links live across Word, Excel, and separate test tools, building a traceability matrix for your medical device takes days and creates gaps that show up during audit. Jama Connect® keeps those relationships current through Live Traceability™, which updates linked artifacts as items change and flags suspect downstream links automatically. 

Excel lacks the audit trails, individual user authentication, and electronic signature support that 21 CFR Part 11 requires. It also can’t maintain live links between requirements, risk items, and test cases, so anyone trying to create a traceability matrix in Excel will find it breaks as soon as the design changes. 

Jira handles task tracking well, but Jira requirements management doesn’t natively support the formal traceability links between requirements, risks, and verification that standards like IEC 62304 expect. Teams typically add plugins or export data into a Jira requirements traceability matrix using spreadsheets, which creates maintenance overhead. Jama Connect® offers a direct Jira integration that keeps engineering work in Jira while maintaining regulated traceability in a purpose-built system. 

No. ISO 13485 certification shows your quality system follows the international standard, but the FDA conducts its own inspections against QMSR requirements, which include provisions beyond what ISO 13485 covers. You still need to address FDA-specific elements like medical device reporting, UDI compliance, and corrections and removals to fully meet FDA requirements for medical devices under 21 CFR Part 820 and ISO 13485. 

You need live traceability between design inputs, outputs, risk items, and test cases, not a tool that makes you build that matrix manually. It also has to support 21 CFR Part 11 compliance out of the box: audit trails, electronic signatures, and individual user authentication. Jama Connect® includes a pre-built medical device framework aligned to design controls, with Live Traceability™ that keeps those links current as the design evolves. 

Excel can’t maintain live traceability links or meet 21 CFR Part 11 audit trail requirements. Jira handles task tracking, but it doesn’t natively support the formal trace chain from user needs through risk analysis to verification that FDA and ISO 13485 expect. Jama Connect® is purpose-built for regulated product development. It connects design controls, risk management, and V&V in one system and produces audit-ready documentation from live data instead of manual assembly.