FFIEC IT Examination HandbookvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how FFIEC IT Examination Handbook 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:
FFIEC IT Examination Handbook maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 6% coverage across 5 directly mapped controls. Analysis of 78 FFIEC IT Examination Handbook controls identifies 73 compliance gaps — primarily concentrated in Information Security.
Source: TheArtOfService Knowledge Graph | 78 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 20 of 20 mapped controls across 3 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
FFIEC IT Examination Handbook: Information Security Governance(10 mappings)
FFIEC IT Examination Handbook: Cybersecurity Controls(2 mappings)
FFIEC IT Examination Handbook: Third-Party Risk Management(8 mappings)
Related Comparisons
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Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between FFIEC IT Examination Handbook and IEC 62304:2015 Medical Device Software Lifecycle Processes?
FFIEC IT Examination Handbook has 78 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 5 overlapping controls (6% coverage). The frameworks diverge most significantly in Information Security, where 46 FFIEC IT Examination Handbook controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between FFIEC IT Examination Handbook and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 78 total FFIEC IT Examination Handbook controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 6% coverage. The remaining 73 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FFIEC IT Examination Handbook to IEC 62304:2015 Medical Device Software Lifecycle Processes?
73 FFIEC IT Examination Handbook controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Information Security with 46 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 FFIEC IT Examination Handbook and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Information Security (46 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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