EIOPA Guidelines on ICT Security and Governance (2023)vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how EIOPA Guidelines on ICT Security and Governance (2023) controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
EIOPA Guidelines on ICT Security and Governance (2023) maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 10% coverage across 5 directly mapped controls. Analysis of 50 EIOPA Guidelines on ICT Security and Governance (2023) controls identifies 45 compliance gaps — primarily concentrated in Information Security.
Source: TheArtOfService Knowledge Graph | 50 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Information Security(6 mappings)
ICT Operations and Change Management(5 mappings)
Proportionality and Governance(3 mappings)
Related Comparisons
Other EIOPA Guidelines on ICT Security and Governance (2023) comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between EIOPA Guidelines on ICT Security and Governance (2023) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
EIOPA Guidelines on ICT Security and Governance (2023) has 50 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 5 overlapping controls (10% coverage). The frameworks diverge most significantly in Information Security, where 31 EIOPA Guidelines on ICT Security and Governance (2023) controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between EIOPA Guidelines on ICT Security and Governance (2023) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 50 total EIOPA Guidelines on ICT Security and Governance (2023) controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 10% 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 EIOPA Guidelines on ICT Security and Governance (2023) to IEC 62304:2015 Medical Device Software Lifecycle Processes?
45 EIOPA Guidelines on ICT Security and Governance (2023) controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Information Security with 31 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 EIOPA Guidelines on ICT Security and Governance (2023) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Information Security (31 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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