IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIST SP 800-146
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIST SP 800-146. 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:
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to NIST SP 800-146 with 5% coverage across 7 directly mapped controls. Analysis of 132 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 151 compliance gaps, primarily concentrated in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes.
Source: TheArtOfService Knowledge Graph | 132 controls analysed | 868 frameworks | 315K+ cross-framework mappings
Control Mappings
Showing 7 of 7 mapped controls across 1 domains. Sign up to explore all 315K+ mappings across 868 frameworks.
Superseded batch representation – IEC 62304:2015 Medical Device Software Lifecycle Processes(7 mappings)
A IEC 62304:2015 Medical Device Software Lifecycle Processes to NIST SP 800-146 crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which NIST SP 800-146 controls your existing IEC 62304:2015 Medical Device Software Lifecycle Processes 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 5% in the header counts how many IEC 62304:2015 Medical Device Software Lifecycle Processes controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many NIST SP 800-146 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 IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other NIST SP 800-146 comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-146?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 132 controls across its framework, while NIST SP 800-146 covers 8 controls. Direct mapping analysis identifies 7 overlapping controls (5% coverage). The frameworks diverge most significantly in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes, where 63 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct NIST SP 800-146 equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-146?
Of 132 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 7 map directly to NIST SP 800-146 controls, representing 5% coverage. The remaining 151 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 NIST SP 800-146?
151 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIST SP 800-146. The highest concentration of gaps is in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes with 63 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 NIST SP 800-146?
The domain with the highest gap count is Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes (63 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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