Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions). Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
31
Gaps Found
6%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) with 6% coverage across 2 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 48 compliance gaps — primarily concentrated in Clause 5 - Software Development Process.

Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 4 - General Requirements(1 mappings)

IEC62304-4.1Quality Management System
ILO-FPRW-Cat5-OSH-SafeHealthyEnvironment-C155-C187-2022AmendmentILO Fundamental Category 5 - Safe and Healthy Working Environment (C155 + C187) + 2022 Amendment Adding OSH as Fundamental Right

Clause 9 - Software Problem Resolution Process(1 mappings)

IEC62304-9.6Analyze Problems for Trends
ILO-FPRW-Cat5-OSH-SafeHealthyEnvironment-C155-C187-2022AmendmentILO Fundamental Category 5 - Safe and Healthy Working Environment (C155 + C187) + 2022 Amendment Adding OSH as Fundamental Right

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

Other ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) comparisons

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) covers 8 controls. Direct mapping analysis identifies 2 overlapping controls (6% coverage). The frameworks diverge most significantly in Clause 5 - Software Development Process, where 8 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)?

Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 2 map directly to ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions) controls — representing 6% coverage. The remaining 48 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 ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)?

48 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions). The highest concentration of gaps is in Clause 5 - Software Development 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 ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)?

The domain with the highest gap count is Clause 5 - Software Development Process (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.