ISO 13485vsNIST AI Risk Management Framework (AI RMF 1.0)
See exactly how ISO 13485 controls map to NIST AI Risk Management Framework (AI RMF 1.0). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to NIST AI Risk Management Framework (AI RMF 1.0) with 16% coverage across 6 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 38 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 3 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
ISO 13485: Patient Data Protection(4 mappings)
ISO 13485: Administrative Safeguards(3 mappings)
ISO 13485: Technical Safeguards(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other NIST AI Risk Management Framework (AI RMF 1.0) comparisons
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What are the key differences between ISO 13485 and NIST AI Risk Management Framework (AI RMF 1.0)?
ISO 13485 has 44 controls across its framework, while NIST AI Risk Management Framework (AI RMF 1.0) covers 52 controls. Direct mapping analysis identifies 6 overlapping controls (16% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct NIST AI Risk Management Framework (AI RMF 1.0) equivalent.
How many controls map between ISO 13485 and NIST AI Risk Management Framework (AI RMF 1.0)?
Of 44 total ISO 13485 controls, 6 map directly to NIST AI Risk Management Framework (AI RMF 1.0) controls — representing 16% coverage. The remaining 38 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 AI Risk Management Framework (AI RMF 1.0)?
38 ISO 13485 controls have no direct equivalent in NIST AI Risk Management Framework (AI RMF 1.0). The highest concentration of gaps is in Product Realisation with 7 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 AI Risk Management Framework (AI RMF 1.0)?
The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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