ISO 13485vsUS Consumer Product Safety Commission (CPSC) - Connected Product Safety
See exactly how ISO 13485 controls map to US Consumer Product Safety Commission (CPSC) - Connected Product Safety. 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 Consumer Product Safety Commission (CPSC) - Connected Product Safety with 34% coverage across 10 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 19 compliance gaps, primarily concentrated in ISO 13485: Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 29 controls analysed | 686 frameworks | 309K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 6 domains. Sign up to explore all 309K+ mappings across 686 frameworks.
Resource Management(1 mappings)
Measurement(2 mappings)
ISO 13485: Patient Data Protection(4 mappings)
ISO 13485: Administrative Safeguards(2 mappings)
ISO 13485: Technical Safeguards(1 mappings)
ISO 13485: Physical Safeguards(1 mappings)
A ISO 13485 to US Consumer Product Safety Commission (CPSC) - Connected Product Safety crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which US Consumer Product Safety Commission (CPSC) - Connected Product Safety 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 34% 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 Consumer Product Safety Commission (CPSC) - Connected Product Safety 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 Consumer Product Safety Commission (CPSC) - Connected Product Safety comparisons
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What are the key differences between ISO 13485 and US Consumer Product Safety Commission (CPSC) - Connected Product Safety?
ISO 13485 has 29 controls across its framework, while US Consumer Product Safety Commission (CPSC) - Connected Product Safety covers 23 controls. Direct mapping analysis identifies 10 overlapping controls (34% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct US Consumer Product Safety Commission (CPSC) - Connected Product Safety equivalent.
How many controls map between ISO 13485 and US Consumer Product Safety Commission (CPSC) - Connected Product Safety?
Of 29 total ISO 13485 controls, 10 map directly to US Consumer Product Safety Commission (CPSC) - Connected Product Safety controls, representing 34% coverage. The remaining 19 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 Consumer Product Safety Commission (CPSC) - Connected Product Safety?
19 ISO 13485 controls have no direct equivalent in US Consumer Product Safety Commission (CPSC) - Connected Product Safety. The highest concentration of gaps is in ISO 13485: Organizational Requirements with 4 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 Consumer Product Safety Commission (CPSC) - Connected Product Safety?
The domain with the highest gap count is ISO 13485: Organizational Requirements (4 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.