IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 21% coverage across 11 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 39 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 25 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(1 mappings)
Clause 5 - Software Development Process(9 mappings)
Requirements(3 mappings)
Design(3 mappings)
Risk Management(4 mappings)
+5 more mappings
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Related Comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 9 controls. Direct mapping analysis identifies 11 overlapping controls (21% 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 11 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 21% coverage. The remaining 39 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
39 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
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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