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Cross-Framework Mapping

AWS Well-Architected Security PillarvsIEC 62304:2015 Medical Device Software Lifecycle Processes

See exactly how AWS Well-Architected Security Pillar controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.

9
Controls Mapped
16
Gaps Found
16%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

AWS Well-Architected Security Pillar maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 16% coverage across 4 directly mapped controls. Analysis of 25 AWS Well-Architected Security Pillar controls identifies 21 compliance gaps — primarily concentrated in AWS Well-Architected Security Pillar: Data Protection in Cloud.

Source: TheArtOfService Knowledge Graph | 25 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

AWS Well-Architected Security Pillar: Cloud Governance(3 mappings)

AWS-WA-01Shared responsibility model definition3 targets
→IEC62304-5.2Software Requirements Analysis
→IEC62304-5.3Software Architectural Design
→IEC62304-7.2Risk Control Measures

AWS Well-Architected Security Pillar: Cloud Infrastructure Security(4 mappings)

AWS-WA-19Image and template hardening2 targets
→IEC62304-4.1Quality Management System
→IEC62304-5.1Software Development Planning
AWS-WA-20Cloud configuration management2 targets
→IEC62304-4.1Quality Management System
→IEC62304-5.1Software Development Planning

AWS Well-Architected Security Pillar: Cloud Operations & Monitoring(2 mappings)

AWS-WA-24Cloud change management2 targets
→IEC62304-8.2Change Control
→IEC62304-9.4Use Change Control Process

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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 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) 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 mappings

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What are the key differences between AWS Well-Architected Security Pillar and IEC 62304:2015 Medical Device Software Lifecycle Processes?

AWS Well-Architected Security Pillar has 25 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 4 overlapping controls (16% coverage). The frameworks diverge most significantly in AWS Well-Architected Security Pillar: Data Protection in Cloud, where 5 AWS Well-Architected Security Pillar controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.

How many controls map between AWS Well-Architected Security Pillar and IEC 62304:2015 Medical Device Software Lifecycle Processes?

Of 25 total AWS Well-Architected Security Pillar controls, 4 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 16% 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 AWS Well-Architected Security Pillar to IEC 62304:2015 Medical Device Software Lifecycle Processes?

21 AWS Well-Architected Security Pillar controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in AWS Well-Architected Security Pillar: Data Protection in Cloud with 5 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 AWS Well-Architected Security Pillar and IEC 62304:2015 Medical Device Software Lifecycle Processes?

The domain with the highest gap count is AWS Well-Architected Security Pillar: Data Protection in Cloud (5 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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