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Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07). Pre-computed mappings, identified gaps, and coverage analysis.

14
Controls Mapped
16
Gaps Found
27%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) with 27% coverage across 8 directly mapped controls. Analysis of 30 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 22 compliance gaps — primarily concentrated in Clause 9 — Software Problem Resolution Process.

Source: TheArtOfService Knowledge Graph | 30 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Clause 4 — General Requirements(2 mappings)

IEC62304-4.1Quality Management System2 targets
→EBA-GL-3.3.1Risk Management Framework
→EBA-GL-3.6.1ICT Project Management

Clause 5 — Software Development Process(6 mappings)

IEC62304-5.1Software Development Planning2 targets
→EBA-GL-3.3.1Risk Management Framework
→EBA-GL-3.6.1ICT Project Management
IEC62304-5.2Software Requirements Analysis2 targets
→EBA-GL-3.2.1ICT Governance
→EBA-GL-3.4.1Information Security Policy
IEC62304-5.3Software Architectural Design2 targets
→EBA-GL-3.2.1ICT Governance
→EBA-GL-3.4.1Information Security Policy

Clause 7 — Software Risk Management Process(4 mappings)

IEC62304-7.2Risk Control Measures2 targets
→EBA-GL-3.2.1ICT Governance
→EBA-GL-3.4.1Information Security Policy
IEC62304-7.4Risk Management of Software Changes2 targets
→EBA-GL-3.3.1Risk Management Framework
→EBA-GL-3.6.1ICT Project Management

Clause 8 — Software Configuration Management Process(1 mappings)

IEC62304-8.2Change Control
→EBA-GL-3.6.3ICT Change Management

Clause 9 — Software Problem Resolution Process(1 mappings)

IEC62304-9.4Use Change Control Process
→EBA-GL-3.6.3ICT Change Management

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

IEC 62304:2015 Medical Device Software Lifecycle Processes vs TISAX — Trusted Information Security Assessment Exchange9 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs ICH Q10 — Pharmaceutical Quality System9 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EIOPA Guidelines on ICT Security and Governance (2023)8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EU GMP Annex 11: Computerised Systems8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EDM Council DCAM — Data Management Capability Assessment Model8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs NIST SP 800-82 Rev 3 — Guide to OT Security8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs SSAE 18 — Attestation Standards (SOC Reporting)8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments8 mappings

Other EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) comparisons

CFTC System Safeguards (17 CFR 37, 38, 39, 49) vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)19 mappingsEIOPA Guidelines on ICT Security and Governance (2023) vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)19 mappingsDefence Security Principles Framework (DSPF) vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)18 mappingsProtective Security Policy Framework (PSPF) Release 2024 vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)18 mappingsSouth Korea Cloud Security Assurance Program (CSAP) vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)18 mappingsCSA CCM v4 vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)17 mappingsPAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)17 mappingsCanada ITSG-33 — IT Security Risk Management vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)17 mappings

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) covers 26 controls. Direct mapping analysis identifies 8 overlapping controls (27% coverage). The frameworks diverge most significantly in Clause 9 — Software Problem Resolution Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)?

Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) controls — representing 27% coverage. The remaining 22 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 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)?

22 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07). The highest concentration of gaps is in Clause 9 — Software Problem Resolution Process with 7 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 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)?

The domain with the highest gap count is Clause 9 — Software Problem Resolution Process (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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