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
COMPARE
vs
46IEC 81001 REQUIREMENTS
0SHARED IN BOTH
46NEW IN IEC 81001
4RETIRED FROM FDA CYBER
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 81001-5-1FDA CYBERSECURITY
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — guidance document, not regulation
Effective period2021 – presentSep 2023 – present
Total requirements4613
SCOPE
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
OPERATIONAL
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
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
46ONLY IN IEC 81001
- • 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
4ONLY IN FDA CYBER
- • SOUP Identification and Management
- • SOUP Risk Assessment
- • SBOM Documentation and Maintenance
- • Open Source License Compliance
OTHER COMPARISONS