IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsFDA Quality Management System Regulation (QMSR)
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR) with 18% coverage across 9 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 41 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 12 of 12 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(2 mappings)
Clause 5 - Software Development Process(4 mappings)
Requirements(1 mappings)
Design(1 mappings)
Risk Management(1 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
Clause 9 - Software Problem Resolution Process(2 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and FDA Quality Management System Regulation (QMSR)?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 9 overlapping controls (18% 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 FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and FDA Quality Management System Regulation (QMSR)?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 9 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 18% coverage. The remaining 41 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 FDA Quality Management System Regulation (QMSR)?
41 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). 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 FDA Quality Management System Regulation (QMSR)?
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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