IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsBRCGS Global Standard for Food Safety Issue 9
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to BRCGS Global Standard for Food Safety Issue 9. 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 BRCGS Global Standard for Food Safety Issue 9 with 18% coverage across 9 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 41 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 25 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4 - General Requirements(2 mappings)
Clause 5 - Software Development Process(9 mappings)
Requirements(3 mappings)
Design(3 mappings)
Risk Management(3 mappings)
+5 more mappings
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Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other BRCGS Global Standard for Food Safety Issue 9 comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and BRCGS Global Standard for Food Safety Issue 9?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while BRCGS Global Standard for Food Safety Issue 9 covers 39 controls. Direct mapping analysis identifies 9 overlapping controls (18% 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 BRCGS Global Standard for Food Safety Issue 9 equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and BRCGS Global Standard for Food Safety Issue 9?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 9 map directly to BRCGS Global Standard for Food Safety Issue 9 controls — representing 18% coverage. The remaining 41 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 BRCGS Global Standard for Food Safety Issue 9?
41 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in BRCGS Global Standard for Food Safety Issue 9. 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 BRCGS Global Standard for Food Safety Issue 9?
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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