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
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Explore individual standards
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14
42
7
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
14
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Risk Management
- • Document Control
- • Design Verification
- + 8 more
42
- • Design and Development Review
- • Management Review
- • Corrective and Preventive Action (CAPA)
- • Complaint Handling
- • Medical Device File
- • Supplier Management
- + 36 more
7
- • RISK CONTROL as it relates to USER INTERFACE design
- • Information for SAFETY as it relates to USABILITY
- • Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- • Identify and describe HAZARD-RELATED USE SCENARIOS
- • Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
- • Establish USER INTERFACE SPECIFICATION
- + 1 more