IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsITAR - International Traffic in Arms Regulations
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ITAR - International Traffic in Arms Regulations. 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 ITAR - International Traffic in Arms Regulations with 15% coverage across 8 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 42 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 8 of 8 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(1 mappings)
Requirements(1 mappings)
Clause 5 - Software Development Process(2 mappings)
Design(1 mappings)
Risk Management(1 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
Clause 9 - Software Problem Resolution Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ITAR - International Traffic in Arms Regulations 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 IEC 62304:2015 Medical Device Software Lifecycle Processes and ITAR - International Traffic in Arms Regulations?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ITAR - International Traffic in Arms Regulations covers 8 controls. Direct mapping analysis identifies 8 overlapping controls (15% 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 ITAR - International Traffic in Arms Regulations equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ITAR - International Traffic in Arms Regulations?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to ITAR - International Traffic in Arms Regulations controls — representing 15% coverage. The remaining 42 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 ITAR - International Traffic in Arms Regulations?
42 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ITAR - International Traffic in Arms Regulations. 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 ITAR - International Traffic in Arms Regulations?
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
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.