IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsEDM Council DCAM — Data Management Capability Assessment Model
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to EDM Council DCAM — Data Management Capability Assessment Model. 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 EDM Council DCAM — Data Management Capability Assessment Model with 27% coverage across 8 directly mapped controls. Analysis of 30 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 22 compliance gaps — primarily concentrated in Clause 9 — Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 4 — General Requirements(1 mappings)
Clause 5 — Software Development Process(7 mappings)
Clause 7 — Software Risk Management Process(4 mappings)
Clause 8 — Software Configuration Management Process(1 mappings)
Clause 9 — Software Problem Resolution Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other EDM Council DCAM — Data Management Capability Assessment Model comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and EDM Council DCAM — Data Management Capability Assessment Model?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while EDM Council DCAM — Data Management Capability Assessment Model covers 24 controls. Direct mapping analysis identifies 8 overlapping controls (27% coverage). The frameworks diverge most significantly in Clause 9 — Software Problem Resolution Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct EDM Council DCAM — Data Management Capability Assessment Model equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and EDM Council DCAM — Data Management Capability Assessment Model?
Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to EDM Council DCAM — Data Management Capability Assessment Model controls — representing 27% coverage. The remaining 22 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 EDM Council DCAM — Data Management Capability Assessment Model?
22 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in EDM Council DCAM — Data Management Capability Assessment Model. The highest concentration of gaps is in Clause 9 — Software Problem Resolution Process with 7 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 EDM Council DCAM — Data Management Capability Assessment Model?
The domain with the highest gap count is Clause 9 — Software Problem Resolution Process (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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