TISAX — Trusted Information Security Assessment ExchangevsIEC 62304:2015 Medical Device Software Lifecycle Processes
See exactly how TISAX — Trusted Information Security Assessment Exchange 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:
TISAX — Trusted Information Security Assessment Exchange maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 11% coverage across 5 directly mapped controls. Analysis of 47 TISAX — Trusted Information Security Assessment Exchange controls identifies 42 compliance gaps — primarily concentrated in Information Security.
Source: TheArtOfService Knowledge Graph | 47 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Information Security(6 mappings)
Assessment and Exchange(2 mappings)
Information Security Management(3 mappings)
Technical and Operational Controls(2 mappings)
Related Comparisons
Other TISAX — Trusted Information Security Assessment Exchange comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
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What are the key differences between TISAX — Trusted Information Security Assessment Exchange and IEC 62304:2015 Medical Device Software Lifecycle Processes?
TISAX — Trusted Information Security Assessment Exchange 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 Information Security, where 31 TISAX — Trusted Information Security Assessment Exchange controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.
How many controls map between TISAX — Trusted Information Security Assessment Exchange and IEC 62304:2015 Medical Device Software Lifecycle Processes?
Of 47 total TISAX — Trusted Information Security Assessment Exchange 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 TISAX — Trusted Information Security Assessment Exchange to IEC 62304:2015 Medical Device Software Lifecycle Processes?
42 TISAX — Trusted Information Security Assessment Exchange controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in Information Security with 31 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 TISAX — Trusted Information Security Assessment Exchange and IEC 62304:2015 Medical Device Software Lifecycle Processes?
The domain with the highest gap count is Information Security (31 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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