FDA Cybersecurity vs ISO 14971
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/cybersecurity-vs-iso-14971
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Explore individual standards
23
3
20
9
What's actually different
StatusCurrent — guidance document, not regulationCurrent — recognized consensus standard
Effective periodSep 2023 – present2019 – present
Total requirements239
Risk integrationCybersecurity risks must integrate with the ISO 14971 risk management fileDefines the risk management framework; all other standards reference it
Plan maintenancePatch management plan updated when new threats or vulnerabilities identifiedRisk management plan required before analysis begins; updated through lifecycle
Document approvalAccepted residual risks require signed statements from an authorized individualRisk management activities assigned to named roles; records in risk file
Most common gapIncomplete threat models lacking system context, interfaces, or environment diagramsRisk management file created after design, not integrated from the beginning
Audit focusPremarket submission completeness; threat model depth; FDA deficiency lettersRisk file traceability: Plan, FMEA, and Report linked as a coherent record
What's shared, what's distinct
3
- • Threat Model Documentation
- • Cybersecurity Risk Assessment
- • SOUP Risk Assessment
20
- • Software Bill of Materials
- • Vulnerability Assessment and Management
- • Patch and Update Management Plan
- • Coordinated Vulnerability Disclosure
- • End-of-Life Cybersecurity Plan
- • Penetration Testing Evidence
- + 14 more
9
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Hazard Identification and Risk Estimation
- • Risk Evaluation Against Acceptability Criteria
- • Risk Control Option Analysis
- + 3 more