IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 21% coverage across 7 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 26 compliance gaps, primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 20 of 23 mapped controls across 4 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
Clause 4 - General Requirements(2 mappings)
Clause 5 - Software Development Process(14 mappings)
Clause 7 - Software Risk Management Process(4 mappings)
+3 more mappings
Plus AI-powered gap analysis, compliance advisory, PDF exports, and cross-mapping for all 686 frameworks.
Create Free Account →Free forever, no credit card required
A IEC 62304:2015 Medical Device Software Lifecycle Processes to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 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 21% 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 686 frameworks, at a fraction of consulting costs.
Free
- ✓ 686 framework browser
- ✓ Cross-framework mappings (310K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 49 controls. Direct mapping analysis identifies 7 overlapping controls (21% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 7 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls, representing 21% coverage. The remaining 26 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
26 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 7 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 ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (7 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.