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.
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 11 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 39 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 20 of 44 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(4 mappings)
Clause 5 - Software Development Process(15 mappings)
Requirements(1 mappings)
+24 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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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 77 controls. Direct mapping analysis identifies 11 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, 11 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 21% coverage. The remaining 39 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?
39 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.
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