ISO 13485vsNIST Privacy Framework
See exactly how ISO 13485 controls map to NIST Privacy Framework. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to NIST Privacy Framework with 41% coverage across 12 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 17 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 22 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Resource Management(1 mappings)
ISO 13485: Patient Data Protection(13 mappings)
ISO 13485: Administrative Safeguards(4 mappings)
ISO 13485: Technical Safeguards(2 mappings)
+2 more mappings
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Related Comparisons
Other ISO 13485 comparisons
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What are the key differences between ISO 13485 and NIST Privacy Framework?
ISO 13485 has 29 controls across its framework, while NIST Privacy Framework covers 8 controls. Direct mapping analysis identifies 12 overlapping controls (41% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct NIST Privacy Framework equivalent.
How many controls map between ISO 13485 and NIST Privacy Framework?
Of 29 total ISO 13485 controls, 12 map directly to NIST Privacy Framework controls — representing 41% coverage. The remaining 17 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to NIST Privacy Framework?
17 ISO 13485 controls have no direct equivalent in NIST Privacy Framework. The highest concentration of gaps is in ISO 13485: Organizational Requirements with 4 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between ISO 13485 and NIST Privacy Framework?
The domain with the highest gap count is ISO 13485: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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