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Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsIMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2). Pre-computed mappings, identified gaps, and coverage analysis.

12
Controls Mapped
21
Gaps Found
21%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) with 21% coverage across 11 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 39 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.

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

Control Mappings

Showing 12 of 12 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 4 - General Requirements(2 mappings)

IEC62304-4.1Quality Management System2 targets
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
→IMO-MSC-FAL-Recover-BackupRestore-ContinuityOfNavigation-LessonsLearned-DrillsIMO MSC-FAL Recover Function - Backup and Restore + Continuity of Navigation + Continuity of Cargo Operations + Continuity of Propulsion + Lessons Learned + Drills + Resilience

Clause 5 - Software Development Process(3 mappings)

IEC62304-5.1Software Development Planning
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
IEC62304-5.2Software Requirements Analysis
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
IEC62304-5.3Software Architectural Design
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA

Requirements(1 mappings)

IEC62304-5.2Software Requirements Analysis
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA

Design(1 mappings)

IEC62304-5.3Software Architectural Design
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA

Risk Management(2 mappings)

IEC62304-7.2Risk Control Measures
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
IEC62304-7.4Risk Management of Software Changes
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA

Clause 7 - Software Risk Management Process(2 mappings)

IEC62304-7.2Risk Control Measures
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA
IEC62304-7.4Risk Management of Software Changes
→IMO-MSC-FAL-Identify-AssetInventory-ThreatsVulnerabilities-CyberRiskAssessment-RolesResponsibilitiesIMO MSC-FAL Identify Function - OT/IT Asset Inventory + Threats + Vulnerabilities + Cyber Risk Assessment + Roles and Responsibilities + Crew + CSO + DPA

Clause 9 - Software Problem Resolution Process(1 mappings)

IEC62304-9.6Analyze Problems for Trends
→IMO-MSC-FAL-Recover-BackupRestore-ContinuityOfNavigation-LessonsLearned-DrillsIMO MSC-FAL Recover Function - Backup and Restore + Continuity of Navigation + Continuity of Cargo Operations + Continuity of Propulsion + Lessons Learned + Drills + Resilience

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

IEC 62304:2015 Medical Device Software Lifecycle Processes vs ICH Q10 - Pharmaceutical Quality System9 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs Annex 11 to EU GMP - Computerised Systems8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs MTCS (Singapore)8 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 NIST SP 800-1467 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs NIST SP 800-1457 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs NIST SP 800-1447 mappings

Other IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) comparisons

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsIEC 62443 vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsAPI 1164 vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsIAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)5 mappingsOWASP ASVS vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsMITRE D3FEND vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsDAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappingsNIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) vs IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)4 mappings

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) covers 8 controls. Direct mapping analysis identifies 11 overlapping controls (21% 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 IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 11 map directly to IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2) controls — representing 21% coverage. The remaining 39 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 IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

39 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2). 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 IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)?

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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