IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsEU GMP Annex 11: Computerised Systems
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to EU GMP Annex 11: Computerised Systems. 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 EU GMP Annex 11: Computerised Systems 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 16 of 16 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 4 — General Requirements(2 mappings)
Clause 5 — Software Development Process(8 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 EU GMP Annex 11: Computerised Systems comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and EU GMP Annex 11: Computerised Systems?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while EU GMP Annex 11: Computerised Systems covers 23 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 EU GMP Annex 11: Computerised Systems equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and EU GMP Annex 11: Computerised Systems?
Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to EU GMP Annex 11: Computerised Systems 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 EU GMP Annex 11: Computerised Systems?
22 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in EU GMP Annex 11: Computerised Systems. 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 EU GMP Annex 11: Computerised Systems?
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.
Related Resources
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