ISO 13485vsNIS2 Directive Implementing Acts
See exactly how ISO 13485 controls map to NIS2 Directive Implementing Acts. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to NIS2 Directive Implementing Acts with 21% coverage across 6 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 23 compliance gaps — primarily concentrated in ISO 13485: Administrative Safeguards.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource Management(1 mappings)
ISO 13485: Patient Data Protection(4 mappings)
ISO 13485: Technical Safeguards(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other NIS2 Directive Implementing Acts comparisons
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What are the key differences between ISO 13485 and NIS2 Directive Implementing Acts?
ISO 13485 has 29 controls across its framework, while NIS2 Directive Implementing Acts covers 8 controls. Direct mapping analysis identifies 6 overlapping controls (21% coverage). The frameworks diverge most significantly in ISO 13485: Administrative Safeguards, where 6 ISO 13485 controls have no direct NIS2 Directive Implementing Acts equivalent.
How many controls map between ISO 13485 and NIS2 Directive Implementing Acts?
Of 29 total ISO 13485 controls, 6 map directly to NIS2 Directive Implementing Acts controls — representing 21% coverage. The remaining 23 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to NIS2 Directive Implementing Acts?
23 ISO 13485 controls have no direct equivalent in NIS2 Directive Implementing Acts. The highest concentration of gaps is in ISO 13485: Administrative Safeguards with 6 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 ISO 13485 and NIS2 Directive Implementing Acts?
The domain with the highest gap count is ISO 13485: Administrative Safeguards (6 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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