Japan AI GuidelinesvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how Japan AI Guidelines 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:
Japan AI Guidelines maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 23% coverage across 3 directly mapped controls. Analysis of 13 Japan AI Guidelines controls identifies 10 compliance gaps — primarily concentrated in JP AI Third-Party + Supply Chain.
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 12 of 12 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
JP AI Continuous Monitoring + Lifecycle(4 mappings)
JP AI Fairness + Bias(4 mappings)
JP AI Safety + AISI(4 mappings)
Related Comparisons
Other Japan AI Guidelines comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes 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 (332K+)
- ✓ 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 Japan AI Guidelines and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Japan AI Guidelines has 13 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 3 overlapping controls (23% coverage). The frameworks diverge most significantly in JP AI Third-Party + Supply Chain, where 1 Japan AI Guidelines controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between Japan AI Guidelines and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 13 total Japan AI Guidelines controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 23% coverage. The remaining 10 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping Japan AI Guidelines to IEC 62304:2015 Medical Device Software Lifecycle Processes?
10 Japan AI Guidelines controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in JP AI Third-Party + Supply Chain with 1 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 Japan AI Guidelines and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is JP AI Third-Party + Supply Chain (1 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.