TheArtOfService
Cross-Framework Mapping

MARS-EvsISO 13485

See exactly how MARS-E controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

32
Controls Mapped
0
Gaps Found
88%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

MARS-E maps to ISO 13485 with 88% coverage across 7 directly mapped controls. Analysis of 8 MARS-E controls identifies 1 compliance gaps — primarily concentrated in Scope and Authority - MARS-E v2.0.

Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 32 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Access Control and Identity Authentication - MARS-E v2.0(6 mappings)

MARS-E-Access-Control-Identity-Authentication-NIST-800-63-Identity-Assurance-Levels-MFA-AC-IA-FamiliesMARS-E Access Control + Identity + Authentication + NIST 800-63 + MFA + AC + IA Families6 targets
→6.4Logging and Monitoring
→ISO13485-01ePHI access controls and authorization
→ISO13485-07Workforce security and clearance procedures
→ISO13485-08Information access management
→ISO13485-12Unique user identification and authentication
→ISO13485-17Facility access controls

Audit Accountability and Continuous Monitoring - MARS-E v2.0(3 mappings)

MARS-E-Audit-Accountability-Continuous-Monitoring-AU-Family-CM-Family-SIEM-Log-Retention-IRS-Pub-1075MARS-E Audit + Accountability + Continuous Monitoring + AU + CM Families + SIEM + IRS Pub 10753 targets
→ISO13485-03Minimum necessary standard enforcement
→ISO13485-04Patient data de-identification procedures
→ISO13485-05Audit trail for ePHI access

Contingency Media Protection System Integrity - MARS-E v2.0(4 mappings)

MARS-E-Contingency-Media-Protection-System-Integrity-CP-MP-SI-Families-DR-COOP-Encryption-SanitizationMARS-E Contingency + Media Protection + System Integrity + CP + MP + SI Families + DR + COOP4 targets
→6.4Logging and Monitoring
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-12Unique user identification and authentication
→ISO13485-16Transmission security and encryption

Cross-Program Coordination - MARS-E v2.0(6 mappings)

MARS-E-Cross-Program-Coordination-IRS-Pub-1075-FedRAMP-CMS-ARS-HHS-OIG-Joint-Audit-3PAOMARS-E Cross-Program + IRS Pub 1075 + FedRAMP + CMS ARS + HHS OIG + Joint Audit + 3PAO6 targets
→ISO13485-01ePHI access controls and authorization
→ISO13485-02ePHI encryption at rest and in transit
→ISO13485-05Audit trail for ePHI access
→ISO13485-08Information access management
→ISO13485-16Transmission security and encryption
→ISO13485-17Facility access controls

Incident Response and Breach Notification - MARS-E v2.0(1 mappings)

MARS-E-Incident-Response-Breach-Notification-IR-Family-45-CFR-164-400-414-IRS-Pub-1075-Notification-CMS-IRTMARS-E Incident Response + Breach Notification + IR Family + 45 CFR 164.400-414 + IRS Pub 1075 + CMS IRT
→ISO13485-01ePHI access controls and authorization

+12 more mappings

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Related Comparisons

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Other ISO 13485 comparisons

NIST SP 800-66 vs ISO 1348513 mappingsMDS2 (Medical Device) vs ISO 1348513 mappingsISO 27799 vs ISO 1348513 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs ISO 1348512 mappingsNIST Privacy Framework vs ISO 1348512 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs ISO 1348512 mappingsOman National Cybersecurity Framework vs ISO 1348511 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs ISO 1348511 mappings

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What are the key differences between MARS-E and ISO 13485?

MARS-E has 8 controls across its framework, while ISO 13485 covers 29 controls. Direct mapping analysis identifies 7 overlapping controls (88% coverage). The frameworks diverge most significantly in Scope and Authority - MARS-E v2.0, where 1 MARS-E controls have no direct ISO 13485 equivalent.

How many controls map between MARS-E and ISO 13485?

Of 8 total MARS-E controls, 7 map directly to ISO 13485 controls — representing 88% coverage. The remaining 1 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping MARS-E to ISO 13485?

1 MARS-E controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Scope and Authority - MARS-E v2.0 with 1 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 MARS-E and ISO 13485?

The domain with the highest gap count is Scope and Authority - MARS-E v2.0 (1 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

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.