IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIS2 Directive Implementing Acts
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIS2 Directive Implementing Acts. 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 Implementing Acts with 9% coverage across 4 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 46 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 4 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
Clause 4 - General Requirements(1 mappings)
Clause 5 - Software Development Process(1 mappings)
Risk Management(1 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other NIS2 Directive Implementing Acts comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (330K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIS2 Directive Implementing Acts?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while NIS2 Directive Implementing Acts covers 8 controls. Direct mapping analysis identifies 4 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct NIS2 Directive Implementing Acts equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIS2 Directive Implementing Acts?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 4 map directly to NIS2 Directive Implementing Acts controls — representing 9% coverage. The remaining 46 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 Implementing Acts?
46 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIS2 Directive Implementing Acts. The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 8 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 Implementing Acts?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.