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    Quality & RiskQuality SystemFMEA

    Failure Mode and Effects Analysis

    Bottom-up technique for systematically identifying potential failures and their effects.

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

    Definition

    FMEA evaluates each component or process step to identify failure modes, their causes, effects, and severity, occurrence, and detectability ratings used to prioritize mitigation. Variants include design FMEA (dFMEA), process FMEA (pFMEA), and use FMEA (uFMEA).

    What this means in practice

    FMEA is a useful input to ISO 14971 risk management but is not, by itself, sufficient - ISO 14971 requires a top-down hazard analysis as well.

    Cross-references

    Used by

    Things that build on this term.

    Often confused with

    Distinct concept frequently mistaken for this one.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    AIAG-VDA·1MDIC·1FDA·1
    1. 1
      AIAG-VDA FMEA Handbook
      Needs review
      AIAG-VDAaiag.org
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

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