IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 9001
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 9001. 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 ISO 9001 with 13% coverage across 4 directly mapped controls. Analysis of 30 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 26 compliance gaps — primarily concentrated in Clause 5 — Software Development Process.
Source: TheArtOfService Knowledge Graph | 30 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Clause 4 — General Requirements(3 mappings)
Clause 8 — Software Configuration Management Process(1 mappings)
Clause 9 — Software Problem Resolution Process(4 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ISO 9001 comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 9001?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while ISO 9001 covers 23 controls. Direct mapping analysis identifies 4 overlapping controls (13% coverage). The frameworks diverge most significantly in Clause 5 — Software Development Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct ISO 9001 equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 9001?
Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 4 map directly to ISO 9001 controls — representing 13% coverage. The remaining 26 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 ISO 9001?
26 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 9001. The highest concentration of gaps is in Clause 5 — Software Development Process with 8 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 ISO 9001?
The domain with the highest gap count is Clause 5 — Software Development Process (8 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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