IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsAS9100D - Aerospace Quality Management System
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to AS9100D - Aerospace Quality Management System. 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 AS9100D - Aerospace Quality Management System 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 | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 20 of 27 mapped controls across 7 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Clause 4 - General Requirements(7 mappings)
Clause 5 - Software Development Process(6 mappings)
Requirements(1 mappings)
Design(1 mappings)
Risk Management(4 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
+7 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other AS9100D - Aerospace Quality Management System comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and AS9100D - Aerospace Quality Management System?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while AS9100D - Aerospace Quality Management System covers 69 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 AS9100D - Aerospace Quality Management System equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and AS9100D - Aerospace Quality Management System?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 11 map directly to AS9100D - Aerospace Quality Management System 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 AS9100D - Aerospace Quality Management System?
39 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in AS9100D - Aerospace Quality Management System. 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 AS9100D - Aerospace Quality Management System?
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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