IEC 62304 vs IEC 81001-5-1
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/iec-62304-vs-iec-81001
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Explore individual standards
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What's actually different
StatusCurrent — recognized consensus standardCurrent — FDA-recognized consensus standard
Effective period2006 – present (Amd 1:2015)2021 – present
Total requirements2646
Risk integrationSoftware-specific risk via ISO 14971; class drives requirement depthSecurity risk management integrated with ISO 14971 safety risk file
Plan maintenanceSoftware development plan updated throughout lifecycleSecure lifecycle plan with annual security review cadence
Document approvalVerification records required per phase and safety classRACI matrix and security role documentation required
Most common gapInternal software controls used to lower safety classificationSecurity activities not integrated into QMS; undocumented roles
Audit focusClassification rationale, SOUP list currency, plan update recordsQMS security integration, RACI completeness, training records per role
What's shared, what's distinct
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- • Software Safety Classification
- • Software Development Planning
- • Software Requirements Analysis
- • Software Architectural Design
- • Software unit implementation
- • Software System Testing
- + 20 more
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- • QMS and Security Responsibilities
- • Identification of Applicability
- • Security Expertise and Training
- • Third-Party Supplier Security
- • Continuous Improvement and Periodic Review
- • Disclosing Security-Related Issues
- + 33 more