IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsOCC Heightened Standards (12 CFR Part 30, Appendix D)
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to OCC Heightened Standards (12 CFR Part 30, Appendix D). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to OCC Heightened Standards (12 CFR Part 30, Appendix D) with 18% coverage across 10 directly mapped controls. Analysis of 34 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 41 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 726 frameworks | 455K+ cross-framework mappings
Control Mappings
Showing 18 of 18 mapped controls across 6 domains. Sign up to explore all 455K+ mappings across 726 frameworks.
Clause 4 - General Requirements(3 mappings)
Clause 5 - Software Development Process(5 mappings)
Requirements(1 mappings)
Design(1 mappings)
Risk Management(4 mappings)
Clause 7 - Software Risk Management Process(4 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other OCC Heightened Standards (12 CFR Part 30, Appendix D) comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and OCC Heightened Standards (12 CFR Part 30, Appendix D)?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 34 controls across its framework, while OCC Heightened Standards (12 CFR Part 30, Appendix D) covers 46 controls. Direct mapping analysis identifies 10 overlapping controls (18% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct OCC Heightened Standards (12 CFR Part 30, Appendix D) equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and OCC Heightened Standards (12 CFR Part 30, Appendix D)?
Of 34 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 10 map directly to OCC Heightened Standards (12 CFR Part 30, Appendix D) controls — representing 18% coverage. The remaining 41 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62304:2015 Medical Device Software Lifecycle Processes to OCC Heightened Standards (12 CFR Part 30, Appendix D)?
41 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in OCC Heightened Standards (12 CFR Part 30, Appendix D). The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 8 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 IEC 62304:2015 Medical Device Software Lifecycle Processes and OCC Heightened Standards (12 CFR Part 30, Appendix D)?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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