IEC 62366 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-62366-vs-iec-81001
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Explore individual standards
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What's actually different
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2015 – present (Amd 1:2020)2021 – present
Total requirements1446
Risk integrationUse-error risks via ISO 14971Cybersecurity risks via ISO 14971
Plan maintenanceUsability Engineering File maintained throughout device lifecycleSecurity Development Life Cycle Plan from conception through decommissioning
Document approvalUsability Evaluation Plan and Report require documented approvalMulti-disciplinary security requirements review; pre-release verification checklist
Most common gapUsability engineering disconnected from risk management fileSecurity risk management siloed from safety risk management
Audit focusUsability File completeness, use scenario traceability, summative coverageThreat model integrity, security-safety integration, penetration test scope
What's shared, what's distinct
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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
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- • QMS and Security Responsibilities
- • Identification of Applicability
- • Security Expertise and Training
- • Third-Party Supplier Security
- • Continuous Improvement and Periodic Review
- • Disclosing Security-Related Issues
- + 40 more