IEC 81001-5-1 vs FDA Cybersecurity
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-81001-vs-cybersecurity
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Explore individual standards
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What's actually different
StatusCurrent — recognized consensus standardCurrent — guidance document, not regulation
Effective period2021 – presentSep 2023 – present
Total requirements4623
Risk integrationCybersecurity risks via ISO 14971 + threat modeling; safety-security integration requiredThreat modeling integrated with ISO 14971; exploitability-based risk (not probabilistic)
Plan maintenanceSecurity lifecycle plan tailored per product; maintained conception through decommissioningPatch and update plan with severity-based SLAs; SBOM updated each software release
Document approvalPre-release security verification checklist; conformance documentation required at releasePremarket submission package; residual risk acceptance signed by risk management authority
Most common gapSecurity risk management siloed from safety risk managementIncomplete threat models lacking system context; risk assessment disconnected from threat model
Audit focusThreat model coverage, SDLC integration, vulnerability monitoring, tester independencePremarket submission completeness; SBOM accuracy; patch SLA compliance; CVD policy published
What's shared, what's distinct
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- No items.
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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
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- • SOUP Identification and Management
- • SOUP Risk Assessment
- • SBOM Documentation and Maintenance
- • Open Source License Compliance
- • Authentication Controls for Medical Devices
- • Authorization Controls and Least Privilege
- + 8 more