APRA CPS 230 Operational Risk ManagementvsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how APRA CPS 230 Operational Risk Management 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:
APRA CPS 230 Operational Risk Management maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 6% coverage across 3 directly mapped controls. Analysis of 47 APRA CPS 230 Operational Risk Management controls identifies 53 compliance gaps — primarily concentrated in Business Continuity.
Source: TheArtOfService Knowledge Graph | 47 controls analysed | 715 frameworks | 418K+ cross-framework mappings
Control Mappings
Showing 12 of 12 mapped controls across 2 domains. Sign up to explore all 418K+ mappings across 715 frameworks.
Operational Risk Management Framework(4 mappings)
Service Provider Management(8 mappings)
Related Comparisons
Other APRA CPS 230 Operational Risk Management comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between APRA CPS 230 Operational Risk Management and IEC 62304:2015 Medical Device Software Lifecycle Processes?
APRA CPS 230 Operational Risk Management has 47 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 34 controls. Direct mapping analysis identifies 3 overlapping controls (6% coverage). The frameworks diverge most significantly in Business Continuity, where 12 APRA CPS 230 Operational Risk Management controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between APRA CPS 230 Operational Risk Management and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 47 total APRA CPS 230 Operational Risk Management controls, 3 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 6% coverage. The remaining 53 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping APRA CPS 230 Operational Risk Management to IEC 62304:2015 Medical Device Software Lifecycle Processes?
53 APRA CPS 230 Operational Risk Management controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Business Continuity with 12 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 APRA CPS 230 Operational Risk Management and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Business Continuity (12 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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