QMSR / ISO 13485 vs IEC 62366
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-62366
vs
Explore individual standards
49
23
40
0
What's actually different
StatusCurrent (effective Feb 2, 2026)Current — IEC 62366-1:2015+AMD1:2020
Effective periodFeb 2026 – present2015 (amended 2020) – present
Total requirements4914
Risk integrationRequired (links to ISO 14971 throughout design)UI hazard analysis feeds directly into ISO 14971 risk file
Plan maintenanceRequired throughout developmentUsability Engineering File maintained through summative evaluation
Document approvalExplicit approval signatures requiredEvaluation plan and report require formal approval before release
Most common gapRisk management file weak or unlinked to designHazard-related use scenarios missing or incomplete summative coverage
Audit focusRisk file integrity and design-control linkageTraceability from use scenarios through summative test results
What's shared, what's distinct
23
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Risk Management
- • Document Control
- • Design Outputs
- + 17 more
40
- • Design and Development Review
- • Management Review
- • Corrective and Preventive Action (CAPA)
- • Complaint Handling
- • Medical Device File
- • Supplier Management
- + 34 more
0
- No items.