IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsAnnex 11 to EU GMP - Computerised Systems
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to Annex 11 to EU GMP - 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 Annex 11 to EU GMP - Computerised Systems with 24% coverage across 13 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 37 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 27 mapped controls across 9 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
Clause 4 - General Requirements(2 mappings)
Clause 5 - Software Development Process(8 mappings)
Requirements(3 mappings)
Design(3 mappings)
Risk Management(4 mappings)
+7 more mappings
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Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and Annex 11 to EU GMP - Computerised Systems?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 13 overlapping controls (24% 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 Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and Annex 11 to EU GMP - Computerised Systems?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 13 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 24% coverage. The remaining 37 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 Annex 11 to EU GMP - Computerised Systems?
37 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in Annex 11 to EU GMP - 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 Annex 11 to EU GMP - 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.
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