BCBS 239vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how BCBS 239 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:
BCBS 239 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 20% coverage across 5 directly mapped controls. Analysis of 25 BCBS 239 controls identifies 20 compliance gaps — primarily concentrated in BCBS 239: Incident Management & Reporting.
Source: TheArtOfService Knowledge Graph | 25 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
BCBS 239: Information Security Governance(6 mappings)
BCBS 239: Cybersecurity Controls(2 mappings)
BCBS 239: Third-Party Risk Management(6 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 BCBS 239 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
BCBS 239 has 25 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 5 overlapping controls (20% coverage). The frameworks diverge most significantly in BCBS 239: Incident Management & Reporting, where 5 BCBS 239 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between BCBS 239 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 25 total BCBS 239 controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 20% coverage. The remaining 20 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping BCBS 239 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
20 BCBS 239 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in BCBS 239: Incident Management & Reporting with 5 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 BCBS 239 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is BCBS 239: Incident Management & Reporting (5 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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