ISO 13485vsFedRAMP Rev 5
See exactly how ISO 13485 controls map to FedRAMP Rev 5. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to FedRAMP Rev 5 with 5% coverage across 1 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 43 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Resource Management(1 mappings)
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What are the key differences between ISO 13485 and FedRAMP Rev 5?
ISO 13485 has 44 controls across its framework, while FedRAMP Rev 5 covers 12 controls. Direct mapping analysis identifies 1 overlapping controls (5% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct FedRAMP Rev 5 equivalent.
How many controls map between ISO 13485 and FedRAMP Rev 5?
Of 44 total ISO 13485 controls, 1 map directly to FedRAMP Rev 5 controls — representing 5% coverage. The remaining 43 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 FedRAMP Rev 5?
43 ISO 13485 controls have no direct equivalent in FedRAMP Rev 5. 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 FedRAMP Rev 5?
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.
Related Resources
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