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.

8
Controls Mapped
21
Gaps Found
28%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to TISAX - Trusted Information Security Assessment Exchange with 28% coverage across 8 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 21 compliance gaps — primarily concentrated in ISO 13485: Administrative Safeguards.

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

Control Mappings

Showing 8 of 8 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

ISO 13485: Patient Data Protection(5 mappings)

ISO13485-01ePHI access controls and authorization
TISAXASS-2ISA Catalog Implementation
ISO13485-02ePHI encryption at rest and in transit
TISAXASS-2ISA Catalog Implementation
ISO13485-03Minimum necessary standard enforcement
TISAXASS-3Prototype Protection and Confidentiality
ISO13485-04Patient data de-identification procedures
TISAXASS-3Prototype Protection and Confidentiality
ISO13485-05Audit trail for ePHI access
TISAXASS-3Prototype Protection and Confidentiality

ISO 13485: Administrative Safeguards(1 mappings)

ISO13485-08Information access management
TISAXASS-2ISA Catalog Implementation

ISO 13485: Technical Safeguards(1 mappings)

ISO13485-16Transmission security and encryption
TISAXASS-2ISA Catalog Implementation

ISO 13485: Physical Safeguards(1 mappings)

ISO13485-17Facility access controls
TISAXASS-2ISA Catalog Implementation

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • 718 framework browser
  • Cross-framework mappings (332K+)
  • 824 compliance assessments
  • 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • Unlimited AI Compliance Advisory
  • Unlimited full-text search
  • Framework self-assessment
  • PDF, Excel & CSV exports
Start 7-Day Free Trial →

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

ISO 13485 has 29 controls across its framework, while TISAX - Trusted Information Security Assessment Exchange covers 4 controls. Direct mapping analysis identifies 8 overlapping controls (28% coverage). The frameworks diverge most significantly in ISO 13485: Administrative Safeguards, where 5 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 29 total ISO 13485 controls, 8 map directly to TISAX - Trusted Information Security Assessment Exchange controls — representing 28% coverage. The remaining 21 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?

21 ISO 13485 controls have no direct equivalent in TISAX - Trusted Information Security Assessment Exchange. The highest concentration of gaps is in ISO 13485: Administrative Safeguards with 5 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: Administrative Safeguards (5 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.