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
COMPARE
vs
11IEC 62304 REQUIREMENTS
0SHARED IN BOTH
11NEW IN IEC 62304
39RETIRED FROM IEC 81001
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 62304IEC 81001-5-1
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — FDA recognized (Consensus Standard 13-122)
Effective period2006 – present (Amd 1:2015)2021 – present
Total requirements1146
SCOPE
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
OPERATIONAL
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
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
11ONLY IN IEC 62304
- • Software Safety Classification
- • Software Development Planning
- • Software Requirements Analysis
- • Software Architectural Design
- • Software unit implementation
- • Software System Testing
- + 5 more
39ONLY IN IEC 81001
- • 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
OTHER COMPARISONS