IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsLloyd's of London Cyber Insurance Requirements and Underwriting Standards
See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to Lloyd's of London Cyber Insurance Requirements and Underwriting Standards. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 62304:2015 Medical Device Software Lifecycle Processes maps to Lloyd's of London Cyber Insurance Requirements and Underwriting Standards with 9% coverage across 4 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 46 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.
Source: TheArtOfService Knowledge Graph | 33 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 4 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Clause 4 - General Requirements(1 mappings)
Clause 5 - Software Development Process(1 mappings)
Risk Management(1 mappings)
Clause 7 - Software Risk Management Process(1 mappings)
Related Comparisons
Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons
Other Lloyd's of London Cyber Insurance Requirements and Underwriting Standards comparisons
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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and Lloyd's of London Cyber Insurance Requirements and Underwriting Standards?
IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while Lloyd's of London Cyber Insurance Requirements and Underwriting Standards covers 8 controls. Direct mapping analysis identifies 4 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 9 - Software Problem Resolution Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct Lloyd's of London Cyber Insurance Requirements and Underwriting Standards equivalent.
How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and Lloyd's of London Cyber Insurance Requirements and Underwriting Standards?
Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 4 map directly to Lloyd's of London Cyber Insurance Requirements and Underwriting Standards controls — representing 9% coverage. The remaining 46 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62304:2015 Medical Device Software Lifecycle Processes to Lloyd's of London Cyber Insurance Requirements and Underwriting Standards?
46 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in Lloyd's of London Cyber Insurance Requirements and Underwriting Standards. The highest concentration of gaps is in Clause 9 - Software Problem Resolution Process with 8 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 IEC 62304:2015 Medical Device Software Lifecycle Processes and Lloyd's of London Cyber Insurance Requirements and Underwriting Standards?
The domain with the highest gap count is Clause 9 - Software Problem Resolution Process (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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