IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs GDPR

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is a healthcare framework applying in International, with 21 controls across 6 domains. GDPR is a privacy framework applying in the European Union, with 41 controls across 5 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)21 controls

GDPR41 controls

Questions people ask about IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR

What is the difference between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR?

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) has 21 controls while GDPR has 41 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.

Do I need both IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR?

Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR so you can identify shared requirements and avoid duplicate effort.

How do IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR controls map to each other?

Our platform maps controls between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.

Which framework should I implement first, IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) or GDPR?

The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.

Each framework on its own

IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

21 controls · Healthcare

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GDPR

41 controls · Privacy

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Comparisons people read next

Each of these compares one of the two standards above against another it shares controls with.

GDPR vs ISO 27701:201933 shared controls GDPR vs AICPA Privacy Management Framework (PMF)30 shared controls GDPR vs NIST SP 800-53 Rev 527 shared controls

See all control mappings with interactive gap analysis

Explore the complete mapping between IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and GDPR on our compliance platform.

Written and maintained by Gerard Blokdyk, The Art of Service.