OSFI B-13vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how OSFI B-13 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:
OSFI B-13 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 38% coverage across 3 directly mapped controls. Analysis of 8 OSFI B-13 controls identifies 5 compliance gaps, primarily concentrated in Metrics and Continuous Improvement.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 3 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
Governance and Three Lines(6 mappings)
Cyber Security (5 NIST CSF Functions)(2 mappings)
Third-Party Risk Management(3 mappings)
A OSFI B-13 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 OSFI B-13 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 38% in the header counts how many OSFI B-13 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
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Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between OSFI B-13 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
OSFI B-13 has 8 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 3 overlapping controls (38% coverage). The frameworks diverge most significantly in Metrics and Continuous Improvement, where 1 OSFI B-13 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between OSFI B-13 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 8 total OSFI B-13 controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls, representing 38% coverage. The remaining 5 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping OSFI B-13 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
5 OSFI B-13 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Metrics and Continuous Improvement with 1 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 OSFI B-13 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Metrics and Continuous Improvement (1 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.