IEEE 1686vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how IEEE 1686 controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEEE 1686 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 29% coverage across 2 directly mapped controls. Analysis of 7 IEEE 1686 controls identifies 5 compliance gaps — primarily concentrated in IEEE 1686 IR + Recovery + Reporting.
Source: TheArtOfService Knowledge Graph | 7 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 9 of 9 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
IEEE 1686 Section 5.5-5.8 - Firmware + Config + Time + Data(5 mappings)
IEEE 1686 Section 6 + Supply Chain + Procurement + Physical(4 mappings)
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 IEEE 1686 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
IEEE 1686 has 7 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 2 overlapping controls (29% coverage). The frameworks diverge most significantly in IEEE 1686 IR + Recovery + Reporting, where 1 IEEE 1686 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between IEEE 1686 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 7 total IEEE 1686 controls, 2 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 29% 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 IEEE 1686 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
5 IEEE 1686 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in IEEE 1686 IR + Recovery + Reporting 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 IEEE 1686 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is IEEE 1686 IR + Recovery + Reporting (1 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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