IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsEASA Part-IS - Information Security in Aviation
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to EASA Part-IS - Information Security in Aviation. 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 EASA Part-IS - Information Security in Aviation with 12% coverage across 5 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 45 compliance gaps — primarily concentrated in Clause 5 - Software Development Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(4 mappings)
Clause 5 - Software Development Process(3 mappings)
Risk Management(3 mappings)
Clause 7 - Software Risk Management Process(3 mappings)
Clause 9 - Software Problem Resolution Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other EASA Part-IS - Information Security in Aviation comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and EASA Part-IS - Information Security in Aviation?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while EASA Part-IS - Information Security in Aviation covers 34 controls. Direct mapping analysis identifies 5 overlapping controls (12% coverage). The frameworks diverge most significantly in Clause 5 - Software Development Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct EASA Part-IS - Information Security in Aviation equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and EASA Part-IS - Information Security in Aviation?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 5 map directly to EASA Part-IS - Information Security in Aviation controls — representing 12% coverage. The remaining 45 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 EASA Part-IS - Information Security in Aviation?
45 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in EASA Part-IS - Information Security in Aviation. The highest concentration of gaps is in Clause 5 - Software Development 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 EASA Part-IS - Information Security in Aviation?
The domain with the highest gap count is Clause 5 - Software Development 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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