APRA CPS 234vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how APRA CPS 234 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 234 maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 14% coverage across 7 directly mapped controls. Analysis of 35 APRA CPS 234 controls identifies 38 compliance gaps — primarily concentrated in APRA CPS 234: Incident Management & Reporting.
Source: TheArtOfService Knowledge Graph | 35 controls analysed | 730 frameworks | 503K+ cross-framework mappings
Control Mappings
Showing 20 of 28 mapped controls across 5 domains. Sign up to explore all 503K+ mappings across 730 frameworks.
APRA CPS 234: Information Security Governance(6 mappings)
APRA CPS 234: Cybersecurity Controls(2 mappings)
Third Party(4 mappings)
APRA CPS 234: Third-Party Risk Management(8 mappings)
+8 more mappings
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Related Comparisons
Other APRA CPS 234 comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between APRA CPS 234 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
APRA CPS 234 has 35 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 34 controls. Direct mapping analysis identifies 7 overlapping controls (14% coverage). The frameworks diverge most significantly in APRA CPS 234: Incident Management & Reporting, where 5 APRA CPS 234 controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between APRA CPS 234 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 35 total APRA CPS 234 controls, 7 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 14% coverage. The remaining 38 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping APRA CPS 234 to IEC 62304:2015 Medical Device Software Lifecycle Processes?
38 APRA CPS 234 controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in APRA CPS 234: 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 APRA CPS 234 and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is APRA CPS 234: 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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