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    ISO/TR 24971

    Guidance on the application of ISO 14971 to medical devices.

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

    Definition

    ISO/TR 24971:2020 provides guidance on developing, implementing, and maintaining a risk management system per ISO 14971, including hazard identification, risk control, residual risk evaluation, and post-production information.

    What this means in practice

    TR 24971 is the de facto playbook for executing ISO 14971 in practice and is frequently referenced by auditors and notified bodies.

    Cross-references

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO/TR 24971:2020
      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.