ISMAP (Japan)vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISMAP (Japan) 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:
ISMAP (Japan) maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 38% coverage across 3 directly mapped controls. Analysis of 8 ISMAP (Japan) controls identifies 5 compliance gaps — primarily concentrated in ISMAP Assessment + International Coordination.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 3 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
ISMAP Cloud Governance(6 mappings)
ISMAP Cloud Infrastructure(2 mappings)
ISMAP Cloud Operations(3 mappings)
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What are the key differences between ISMAP (Japan) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISMAP (Japan) has 8 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 3 overlapping controls (38% coverage). The frameworks diverge most significantly in ISMAP Assessment + International Coordination, where 1 ISMAP (Japan) controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISMAP (Japan) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 8 total ISMAP (Japan) controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 38% coverage. The remaining 5 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISMAP (Japan) to IEC 62304:2015 Medical Device Software Lifecycle Processes?
5 ISMAP (Japan) controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in ISMAP Assessment + International Coordination with 1 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 ISMAP (Japan) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is ISMAP Assessment + International Coordination (1 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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