ISO/IEC 17025:2017 - General Requirements for Testing and CalibrationvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. 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/IEC 17025:2017 - General Requirements for Testing and Calibration maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 7% coverage across 5 directly mapped controls. Analysis of 72 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls identifies 74 compliance gaps, primarily concentrated in Superseded batch representation – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration.
Source: TheArtOfService Knowledge Graph | 72 controls analysed | 686 frameworks | 306K+ cross-framework mappings
Control Mappings
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Superseded batch representation – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration(11 mappings)
A ISO/IEC 17025:2017 - General Requirements for Testing and Calibration to IEC 62304:2015 Medical Device Software Lifecycle Processes crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which IEC 62304:2015 Medical Device Software Lifecycle Processes controls your existing ISO/IEC 17025:2017 - General Requirements for Testing and Calibration 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 7% in the header counts how many ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many IEC 62304:2015 Medical Device Software Lifecycle Processes 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/IEC 17025:2017 - General Requirements for Testing and Calibration comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration and IEC 62304:2015 Medical Device Software Lifecycle Processes?
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration has 72 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 5 overlapping controls (7% coverage). The frameworks diverge most significantly in Superseded batch representation – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration, where 28 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 72 total ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls, representing 7% coverage. The remaining 74 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 17025:2017 - General Requirements for Testing and Calibration to IEC 62304:2015 Medical Device Software Lifecycle Processes?
74 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Superseded batch representation – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration with 28 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/IEC 17025:2017 - General Requirements for Testing and Calibration and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Superseded batch representation – ISO/IEC 17025:2017 - General Requirements for Testing and Calibration (28 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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