QMSR / ISO 13485 vs IEC 62304
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/qmsr-vs-iec-62304
COMPARE
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39QMSR REQUIREMENTS
0SHARED IN BOTH
39NEW IN QMSR
0RETIRED FROM IEC 62304
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONQMSR / ISO 13485IEC 62304
OVERVIEW
StatusCurrent (effective Feb 2, 2026)Current — IEC 62304:2006+AMD1:2015
Effective periodFeb 2026 – present2006 (amended 2015) – present
Total requirements3911
SCOPE
Risk integrationRequired (links to ISO 14971 throughout design)Required — software safety class drives lifecycle rigor
Plan maintenanceRequired throughout developmentUpdated at each phase gate per development plan
Document approvalExplicit approval signatures requiredFormal checklist approval before each lifecycle phase
OPERATIONAL
Most common gapRisk management file weak or unlinked to designSafety class under-assigned; traceability matrix incomplete
Audit focusRisk file integrity and design-control linkageSafety classification rationale and requirements traceability
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
39ONLY IN QMSR
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 33 more
0ONLY IN IEC 62304
- No items.
OTHER COMPARISONS