SSAE 18 — Attestation Standards (SOC Reporting)vsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how SSAE 18 — Attestation Standards (SOC Reporting) 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:
SSAE 18 — Attestation Standards (SOC Reporting) maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 11% coverage across 5 directly mapped controls. Analysis of 47 SSAE 18 — Attestation Standards (SOC Reporting) controls identifies 42 compliance gaps — primarily concentrated in SOC 2 — Logical and Physical Access Controls.
Source: TheArtOfService Knowledge Graph | 47 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
SOC 2 — Security (Common Criteria)(2 mappings)
SOC 2 — System Operations and Change Management(8 mappings)
SOC 2 — Additional Trust Services Categories(3 mappings)
Related Comparisons
Other SSAE 18 — Attestation Standards (SOC Reporting) comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between SSAE 18 — Attestation Standards (SOC Reporting) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
SSAE 18 — Attestation Standards (SOC Reporting) has 47 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 5 overlapping controls (11% coverage). The frameworks diverge most significantly in SOC 2 — Logical and Physical Access Controls, where 11 SSAE 18 — Attestation Standards (SOC Reporting) controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between SSAE 18 — Attestation Standards (SOC Reporting) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 47 total SSAE 18 — Attestation Standards (SOC Reporting) controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 11% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping SSAE 18 — Attestation Standards (SOC Reporting) to IEC 62304:2015 Medical Device Software Lifecycle Processes?
42 SSAE 18 — Attestation Standards (SOC Reporting) controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in SOC 2 — Logical and Physical Access Controls with 11 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 SSAE 18 — Attestation Standards (SOC Reporting) and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is SOC 2 — Logical and Physical Access Controls (11 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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