ISO 13485vs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how ISO 13485 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 11% 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 | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
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What are the key differences between ISO 13485 and 21 CFR Part 211 - Current Good Manufacturing Practice?
ISO 13485 has 44 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 1 overlapping controls (11% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between ISO 13485 and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 44 total ISO 13485 controls, 1 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 11% 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 21 CFR Part 211 - Current Good Manufacturing Practice?
43 ISO 13485 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. 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 21 CFR Part 211 - Current Good Manufacturing Practice?
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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