TheArtOfService
Cross-Framework Mapping

ISO 13485vsMARS-E

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

32
Controls Mapped
0
Gaps Found
45%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to MARS-E with 45% coverage across 13 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 16 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 29 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 32 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Resource Management(2 mappings)

6.4Logging and Monitoring2 targets
→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 Families
→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 + COOP

ISO 13485: Patient Data Protection(14 mappings)

ISO13485-01ePHI access controls and authorization4 targets
→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 Families
→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 + 3PAO
→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
→MARS-E-Privacy-PII-PHI-Minimum-Necessary-HIPAA-Privacy-Rule-NIST-800-122-45-CFR-164-Subpart-EMARS-E Privacy + PII + PHI + Minimum Necessary + HIPAA Privacy Rule + NIST 800-122 + 45 CFR 164 Subpart E
ISO13485-02ePHI encryption at rest and in transit3 targets
→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 + COOP
→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 + 3PAO
→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
ISO13485-03Minimum necessary standard enforcement2 targets
→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 1075
→MARS-E-Privacy-PII-PHI-Minimum-Necessary-HIPAA-Privacy-Rule-NIST-800-122-45-CFR-164-Subpart-EMARS-E Privacy + PII + PHI + Minimum Necessary + HIPAA Privacy Rule + NIST 800-122 + 45 CFR 164 Subpart E
ISO13485-04Patient data de-identification procedures2 targets
→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 1075
→MARS-E-Privacy-PII-PHI-Minimum-Necessary-HIPAA-Privacy-Rule-NIST-800-122-45-CFR-164-Subpart-EMARS-E Privacy + PII + PHI + Minimum Necessary + HIPAA Privacy Rule + NIST 800-122 + 45 CFR 164 Subpart E
ISO13485-05Audit trail for ePHI access3 targets
→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 1075
→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 + 3PAO
→MARS-E-Privacy-PII-PHI-Minimum-Necessary-HIPAA-Privacy-Rule-NIST-800-122-45-CFR-164-Subpart-EMARS-E Privacy + PII + PHI + Minimum Necessary + HIPAA Privacy Rule + NIST 800-122 + 45 CFR 164 Subpart E

ISO 13485: Administrative Safeguards(4 mappings)

ISO13485-06Security management process and risk analysis
→MARS-E-NIST-800-53-Moderate-Baseline-Catalog-v2-0-Volume-III-Tailoring-Risk-Assessment-CategorizationMARS-E NIST 800-53 Moderate Baseline + MARS-E Catalog Volume III + Tailoring + Risk Assessment + Categorization
ISO13485-07Workforce security and clearance procedures
→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 Families
ISO13485-08Information access management2 targets
→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 Families
→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 + 3PAO

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Related Comparisons

Other ISO 13485 comparisons

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Other MARS-E comparisons

Turkey KVKK vs MARS-E7 mappingsPrivacy Act 1988 (Australia) vs MARS-E7 mappingsISO 27018 vs MARS-E7 mappingsISO 27799 vs MARS-E7 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs MARS-E7 mappingsAWS Well-Architected Security Pillar vs MARS-E7 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs MARS-E7 mappingsFederal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL) vs MARS-E7 mappings

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

ISO 13485 has 29 controls across its framework, while MARS-E covers 8 controls. Direct mapping analysis identifies 13 overlapping controls (45% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct MARS-E equivalent.

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

Of 29 total ISO 13485 controls, 13 map directly to MARS-E controls — representing 45% coverage. The remaining 16 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

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

16 ISO 13485 controls have no direct equivalent in MARS-E. The highest concentration of gaps is in ISO 13485: Organizational Requirements with 4 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 ISO 13485 and MARS-E?

The domain with the highest gap count is ISO 13485: Organizational Requirements (4 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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