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    ISO 13485

    International standard for medical device quality management systems.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

    What this means in practice

    ISO 13485 is referenced or required by regulators worldwide, including the EU (under MDR/IVDR) and Health Canada. FDA's QMSR explicitly incorporates ISO 13485:2016 by reference.

    Use cases

    1 scenario
    1

    Contract manufacturer onboarding a new medical device customer

    Quality Manager

    A CMO holds an ISO 13485 certificate from a notified body. A new EU MDR customer audits the QMS, confirms design transfer, supplier control, and CAPA processes meet the standard, and adds the CMO to their approved supplier list.

    OutcomeOnboarding takes 6 weeks instead of 6 months because the QMS is already evidence-based and audited.

    Cross-references

    Used by

    Things that build on this term.

    Overlaps with

    Covers some of the same ground; not interchangeable.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 13485:2016
      Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.