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    Quality & RiskQuality SystemRMF

    Risk Management File

    Set of records and outputs from the ISO 14971 risk management process.

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

    Definition

    The Risk Management File is the set of records and other documents that are produced by the risk management process for a medical device, providing traceability for each identified hazard from analysis through control and post-production information.

    What this means in practice

    Regulators expect a living RMF that is updated based on post-market data, complaints, and field events - not a static premarket artifact.

    Cross-references

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 14971:2019
      Verified
      ISOiso.org
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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