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Cross-Framework Mapping

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

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

14
Controls Mapped
12
Gaps Found
19%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 19% coverage across 5 directly mapped controls. Analysis of 26 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) controls identifies 21 compliance gaps — primarily concentrated in 3.4 Information Security.

Source: TheArtOfService Knowledge Graph | 26 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

3.2 Governance and Strategy(3 mappings)

EBA-GL-3.2.1ICT Governance3 targets
→IEC62304-5.2Software Requirements Analysis
→IEC62304-5.3Software Architectural Design
→IEC62304-7.2Risk Control Measures

3.3 ICT and Security Risk Management Framework(3 mappings)

EBA-GL-3.3.1Risk Management Framework3 targets
→IEC62304-4.1Quality Management System
→IEC62304-5.1Software Development Planning
→IEC62304-7.4Risk Management of Software Changes

3.4 Information Security(3 mappings)

EBA-GL-3.4.1Information Security Policy3 targets
→IEC62304-5.2Software Requirements Analysis
→IEC62304-5.3Software Architectural Design
→IEC62304-7.2Risk Control Measures

3.6 ICT Project and Change Management(5 mappings)

EBA-GL-3.6.1ICT Project Management3 targets
→IEC62304-4.1Quality Management System
→IEC62304-5.1Software Development Planning
→IEC62304-7.4Risk Management of Software Changes
EBA-GL-3.6.3ICT Change Management2 targets
→IEC62304-8.2Change Control
→IEC62304-9.4Use Change Control Process

Related Comparisons

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

EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs CFTC System Safeguards (17 CFR 37, 38, 39, 49)19 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs EIOPA Guidelines on ICT Security and Governance (2023)19 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs Defence Security Principles Framework (DSPF)18 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs Protective Security Policy Framework (PSPF) Release 202418 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs South Korea Cloud Security Assurance Program (CSAP)18 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs CSA CCM v417 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments17 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs Canada ITSG-33 — IT Security Risk Management17 mappings

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

TISAX — Trusted Information Security Assessment Exchange vs IEC 62304:2015 Medical Device Software Lifecycle Processes9 mappingsICH Q10 — Pharmaceutical Quality System vs IEC 62304:2015 Medical Device Software Lifecycle Processes9 mappingsEIOPA Guidelines on ICT Security and Governance (2023) vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappingsEU GMP Annex 11: Computerised Systems vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappingsEDM Council DCAM — Data Management Capability Assessment Model vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappingsNIST SP 800-82 Rev 3 — Guide to OT Security vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappingsSSAE 18 — Attestation Standards (SOC Reporting) vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappingsPAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments vs IEC 62304:2015 Medical Device Software Lifecycle Processes8 mappings

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

EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) has 26 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 5 overlapping controls (19% coverage). The frameworks diverge most significantly in 3.4 Information Security, where 6 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.

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

Of 26 total EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) controls, 5 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 19% coverage. The remaining 21 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) to IEC 62304:2015 Medical Device Software Lifecycle Processes?

21 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in 3.4 Information Security with 6 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 EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) and IEC 62304:2015 Medical Device Software Lifecycle Processes?

The domain with the highest gap count is 3.4 Information Security (6 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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