Cross-Framework Mapping

ISO 13485vsTISAX — Trusted Information Security Assessment Exchange

See exactly how ISO 13485 controls map to TISAX — Trusted Information Security Assessment Exchange. Pre-computed mappings, identified gaps, and coverage analysis.

34
Controls Mapped
0
Gaps Found
50%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to TISAX — Trusted Information Security Assessment Exchange with 50% coverage across 12 directly mapped controls. Analysis of 24 ISO 13485 controls identifies 12 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 34 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

ISO 13485: Patient Data Protection(19 mappings)

ISO13485-01ePHI access controls and authorization4 targets
DSPF-INFO-3Information Access Controls
EIOPA-GL-8Logical Security
TISAX-IS-01ISMS Requirements
TISAX-TECH-01Access Control and Identity Management
ISO13485-02ePHI encryption at rest and in transit3 targets
GLI33-4.3Data Protection and Encryption
TISAX-IS-01ISMS Requirements
TISAX-TECH-02Cryptography
ISO13485-03Minimum necessary standard enforcement3 targets
GLI33-4.3Data Protection and Encryption
TISAX-PROT-03Data Protection (Privacy)
TSSR-INFO-1Network Data Protection
ISO13485-04Patient data de-identification procedures3 targets
GLI33-4.3Data Protection and Encryption
TISAX-PROT-03Data Protection (Privacy)
TSSR-INFO-1Network Data Protection
ISO13485-05Audit trail for ePHI access6 targets
GLI33-4.3Data Protection and Encryption
GLI33-4.4Audit Trail and Logging
TISAX-PROT-01Prototype Protection (Physical)
TISAX-PROT-03Data Protection (Privacy)
TISAX-TECH-03Operations and Communications Security
TSSR-INFO-1Network Data Protection

ISO 13485: Administrative Safeguards(1 mappings)

ISO13485-06Security management process and risk analysis
38.1051(a)General Security Requirements for DCMs

+14 more mappings

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Related Comparisons

Other ISO 13485 comparisons

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What are the key differences between ISO 13485 and TISAX — Trusted Information Security Assessment Exchange?

ISO 13485 has 24 controls across its framework, while TISAX — Trusted Information Security Assessment Exchange covers 47 controls. Direct mapping analysis identifies 12 overlapping controls (50% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct TISAX — Trusted Information Security Assessment Exchange equivalent.

How many controls map between ISO 13485 and TISAX — Trusted Information Security Assessment Exchange?

Of 24 total ISO 13485 controls, 12 map directly to TISAX — Trusted Information Security Assessment Exchange controls — representing 50% coverage. The remaining 12 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 TISAX — Trusted Information Security Assessment Exchange?

12 ISO 13485 controls have no direct equivalent in TISAX — Trusted Information Security Assessment Exchange. 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 TISAX — Trusted Information Security Assessment Exchange?

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.

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.