IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 39001:2012 - Road Traffic Safety Management
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 39001:2012 - Road Traffic Safety Management. 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 39001:2012 - Road Traffic Safety Management with 15% coverage across 8 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 42 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 24 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(3 mappings)
Requirements(3 mappings)
Clause 5 - Software Development Process(6 mappings)
Design(3 mappings)
Risk Management(3 mappings)
Clause 7 - Software Risk Management Process(2 mappings)
+4 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ISO 39001:2012 - Road Traffic Safety Management comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 39001:2012 - Road Traffic Safety Management?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ISO 39001:2012 - Road Traffic Safety Management covers 169 controls. Direct mapping analysis identifies 8 overlapping controls (15% 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 ISO 39001:2012 - Road Traffic Safety Management equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 39001:2012 - Road Traffic Safety Management?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to ISO 39001:2012 - Road Traffic Safety Management controls — representing 15% coverage. The remaining 42 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 39001:2012 - Road Traffic Safety Management?
42 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 39001:2012 - Road Traffic Safety Management. 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 ISO 39001:2012 - Road Traffic Safety Management?
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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