NIS2 DirectivevsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how NIS2 Directive 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:
NIS2 Directive maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 9% coverage across 7 directly mapped controls. Analysis of 80 NIS2 Directive controls identifies 73 compliance gaps — primarily concentrated in Other.
Source: TheArtOfService Knowledge Graph | 80 controls analysed | 768 frameworks | 815K+ cross-framework mappings
Control Mappings
Showing 20 of 29 mapped controls across 5 domains. Sign up to explore all 815K+ mappings across 768 frameworks.
Incident Reporting(6 mappings)
Other(6 mappings)
Governance(6 mappings)
NIS2 Directive: Systems Security(2 mappings)
+9 more mappings
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Related Comparisons
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Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between NIS2 Directive and IEC 62304:2015 Medical Device Software Lifecycle Processes?
NIS2 Directive has 80 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 7 overlapping controls (9% coverage). The frameworks diverge most significantly in Other, where 16 NIS2 Directive controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between NIS2 Directive and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 80 total NIS2 Directive controls, 7 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 9% coverage. The remaining 73 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping NIS2 Directive to IEC 62304:2015 Medical Device Software Lifecycle Processes?
73 NIS2 Directive controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Other with 16 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 NIS2 Directive and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Other (16 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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