API 1164vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how API 1164 controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
API 1164 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 17% coverage across 4 directly mapped controls. Analysis of 24 API 1164 controls identifies 20 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 9 of 9 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
API 1164: Systems Security(2 mappings)
API 1164: Supply Chain & Configuration(7 mappings)
Related Comparisons
Other API 1164 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between API 1164 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
API 1164 has 24 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 4 overlapping controls (17% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between API 1164 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 24 total API 1164 controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 17% coverage. The remaining 20 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping API 1164 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
20 API 1164 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is API 1164: Incident Response & Recovery (5 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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