ISO 13485vsUS ITAR and EAR - Export Control and Data Security
See exactly how ISO 13485 controls map to US ITAR and EAR - Export Control and Data Security. Pre-computed mappings, identified gaps, and coverage analysis.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to US ITAR and EAR - Export Control and Data Security with 28% coverage across 8 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 21 compliance gaps, primarily concentrated in ISO 13485: Administrative Safeguards.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 686 frameworks | 309K+ cross-framework mappings
Control Mappings
Showing 10 of 10 mapped controls across 4 domains. Sign up to explore all 309K+ mappings across 686 frameworks.
ISO 13485: Patient Data Protection(6 mappings)
ISO 13485: Administrative Safeguards(1 mappings)
ISO 13485: Technical Safeguards(2 mappings)
ISO 13485: Physical Safeguards(1 mappings)
A ISO 13485 to US ITAR and EAR - Export Control and Data Security crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which US ITAR and EAR - Export Control and Data Security controls your existing ISO 13485 work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 28% in the header counts how many ISO 13485 controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many US ITAR and EAR - Export Control and Data Security controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
Related Comparisons
Other ISO 13485 comparisons
Other US ITAR and EAR - Export Control and Data Security comparisons
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What are the key differences between ISO 13485 and US ITAR and EAR - Export Control and Data Security?
ISO 13485 has 29 controls across its framework, while US ITAR and EAR - Export Control and Data Security covers 20 controls. Direct mapping analysis identifies 8 overlapping controls (28% coverage). The frameworks diverge most significantly in ISO 13485: Administrative Safeguards, where 5 ISO 13485 controls have no direct US ITAR and EAR - Export Control and Data Security equivalent.
How many controls map between ISO 13485 and US ITAR and EAR - Export Control and Data Security?
Of 29 total ISO 13485 controls, 8 map directly to US ITAR and EAR - Export Control and Data Security controls, representing 28% coverage. The remaining 21 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 US ITAR and EAR - Export Control and Data Security?
21 ISO 13485 controls have no direct equivalent in US ITAR and EAR - Export Control and Data Security. The highest concentration of gaps is in ISO 13485: Administrative Safeguards with 5 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 US ITAR and EAR - Export Control and Data Security?
The domain with the highest gap count is ISO 13485: Administrative Safeguards (5 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.