EDM Council DCAM — Data Management Capability Assessment ModelvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how EDM Council DCAM — Data Management Capability Assessment Model 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:
EDM Council DCAM — Data Management Capability Assessment Model maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 21% coverage across 5 directly mapped controls. Analysis of 24 EDM Council DCAM — Data Management Capability Assessment Model controls identifies 19 compliance gaps — primarily concentrated in Component 8: Analytics Management.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Component 2: Data Management Program and Funding(2 mappings)
Component 5: Data Quality Management(6 mappings)
Component 6: Data Governance(3 mappings)
Component 7: Data Management Operations, Risk and Control(3 mappings)
Related Comparisons
Other EDM Council DCAM — Data Management Capability Assessment Model comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between EDM Council DCAM — Data Management Capability Assessment Model and IEC 62304:2015 Medical Device Software Lifecycle Processes?
EDM Council DCAM — Data Management Capability Assessment Model has 24 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 5 overlapping controls (21% coverage). The frameworks diverge most significantly in Component 8: Analytics Management, where 3 EDM Council DCAM — Data Management Capability Assessment Model controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between EDM Council DCAM — Data Management Capability Assessment Model and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 24 total EDM Council DCAM — Data Management Capability Assessment Model controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 21% coverage. The remaining 19 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping EDM Council DCAM — Data Management Capability Assessment Model to IEC 62304:2015 Medical Device Software Lifecycle Processes?
19 EDM Council DCAM — Data Management Capability Assessment Model controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Component 8: Analytics Management with 3 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 EDM Council DCAM — Data Management Capability Assessment Model and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Component 8: Analytics Management (3 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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