IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIS2 Directive
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIS2 Directive. 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 NIS2 Directive with 24% coverage across 13 directly mapped controls. Analysis of 34 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 38 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 34 controls analysed | 725 frameworks | 447K+ cross-framework mappings
Control Mappings
Showing 20 of 29 mapped controls across 9 domains. Sign up to explore all 447K+ mappings across 725 frameworks.
Clause 4 - General Requirements(3 mappings)
Clause 5 - Software Development Process(9 mappings)
Requirements(3 mappings)
Design(3 mappings)
Risk Management(2 mappings)
+9 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other NIS2 Directive comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIS2 Directive?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 34 controls across its framework, while NIS2 Directive covers 80 controls. Direct mapping analysis identifies 13 overlapping controls (24% 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 NIS2 Directive equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIS2 Directive?
Of 34 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 13 map directly to NIS2 Directive controls — representing 24% coverage. The remaining 38 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 NIS2 Directive?
38 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIS2 Directive. 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 NIS2 Directive?
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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