BRCGS Global Standard for Food Safety Issue 9vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how BRCGS Global Standard for Food Safety Issue 9 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:
BRCGS Global Standard for Food Safety Issue 9 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 18% coverage across 7 directly mapped controls. Analysis of 39 BRCGS Global Standard for Food Safety Issue 9 controls identifies 32 compliance gaps — primarily concentrated in Food Safety Plan (HACCP).
Source: TheArtOfService Knowledge Graph | 39 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
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Senior Management Commitment(14 mappings)
Food Safety and Quality Management System(6 mappings)
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What are the key differences between BRCGS Global Standard for Food Safety Issue 9 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
BRCGS Global Standard for Food Safety Issue 9 has 39 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 7 overlapping controls (18% coverage). The frameworks diverge most significantly in Food Safety Plan (HACCP), where 4 BRCGS Global Standard for Food Safety Issue 9 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between BRCGS Global Standard for Food Safety Issue 9 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 39 total BRCGS Global Standard for Food Safety Issue 9 controls, 7 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 18% coverage. The remaining 32 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping BRCGS Global Standard for Food Safety Issue 9 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
32 BRCGS Global Standard for Food Safety Issue 9 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Food Safety Plan (HACCP) with 4 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 BRCGS Global Standard for Food Safety Issue 9 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Food Safety Plan (HACCP) (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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