IEC 62304 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/iec-62304-vs-iec-62366
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Explore individual standards
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What's actually different
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2006 – present (Amd 1:2015)2015 – present (Amd 1:2020)
Total requirements2614
Risk integrationSoftware-specific risk via ISO 14971; class drives requirement depthUse-error risk linked bidirectionally to ISO 14971 risk file
Plan maintenanceSoftware development plan updated throughout lifecycleUsability evaluation plan maintained through device lifecycle
Document approvalFormal verification records required per class and phaseUsability engineering file with traceable evaluation records
Most common gapInternal software controls used to lower safety classificationUsability engineering disconnected from risk management file
Audit focusClassification rationale, SOUP list currency, plan update recordsUse-error to hazard traceability, summative evaluation completeness
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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- • Usability Engineering Process
- • Usability Engineering File
- • Use Specification
- • Identify known or foreseeable Hazards and Hazardous Situations
- • Establish User Interface Evaluation plan
- • Perform Summative Evaluation of the Usability of the User Interface
- + 8 more