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Cross-Framework Mapping

ISO 13485vsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

See exactly how ISO 13485 controls map to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. Pre-computed mappings, identified gaps, and coverage analysis.

21
Controls Mapped
8
Gaps Found
41%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements with 41% coverage across 12 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 17 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 29 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 21 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Resource Management(2 mappings)

6.4Logging and Monitoring2 targets
→3.7Establish and Maintain a Data Classification Scheme
→3.7.1Key generation procedures

Improvement(3 mappings)

8.5Control effectiveness review3 targets
→3.1Physical Security
→3.2Establish and Maintain a Data Inventory
→3.4Enforce Data Retention

ISO 13485: Patient Data Protection(6 mappings)

ISO13485-01ePHI access controls and authorization2 targets
→3.10Encrypt Sensitive Data in Transit
→3.7.1Key generation procedures
ISO13485-02ePHI encryption at rest and in transit3 targets
→FEDRAMP-SC-13Cryptographic Protection
→FEDRAMP-SC-28Protection of Information at Rest
→FEDRAMP-SC-8Transmission Confidentiality and Integrity
ISO13485-05Audit trail for ePHI access
→3.3.1Audit Record Creation

ISO 13485: Administrative Safeguards(4 mappings)

ISO13485-06Security management process and risk analysis
→3.11Encrypt Sensitive Data at Rest
ISO13485-07Workforce security and clearance procedures
→3.9Encrypt Data on Removable Media
ISO13485-08Information access management
→3.10Encrypt Sensitive Data in Transit
ISO13485-09Security awareness and training program
→3.2.1Account data storage minimised

ISO 13485: Technical Safeguards(5 mappings)

ISO13485-12Unique user identification and authentication2 targets
→3.7Establish and Maintain a Data Classification Scheme
→3.7.1Key generation procedures
ISO13485-16Transmission security and encryption3 targets
→FEDRAMP-SC-13Cryptographic Protection
→FEDRAMP-SC-28Protection of Information at Rest
→FEDRAMP-SC-8Transmission Confidentiality and Integrity

+1 more mappings

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Related Comparisons

Other ISO 13485 comparisons

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Other NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements comparisons

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements20 mappingsNIST SP 800-53 Rev 5 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements18 mappingsMTCS (Singapore) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements17 mappingsNIST Privacy Framework vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements16 mappingsNIST SP 800-146 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-145 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsNIST SP 800-144 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappingsISMAP (Japan) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements15 mappings

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What are the key differences between ISO 13485 and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

ISO 13485 has 29 controls across its framework, while NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements covers 35 controls. Direct mapping analysis identifies 12 overlapping controls (41% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements equivalent.

How many controls map between ISO 13485 and NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

Of 29 total ISO 13485 controls, 12 map directly to NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls — representing 41% coverage. The remaining 17 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

17 ISO 13485 controls have no direct equivalent in NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements. 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements?

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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