MedTech Terms
    The authoritative reference
    All terms
    Quality & RiskQuality System

    Risk Acceptability Matrix

    Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.

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

    Definition

    Required by ISO 14971, the risk acceptability matrix is the manufacturer's policy on how risk levels translate into action. It must be defined before risk evaluation and applied consistently across the risk management file.

    What this means in practice

    Notified Bodies frequently challenge inconsistent or unjustified matrices; aligning to ISO/TR 24971 examples is a defensible starting point.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1AAMI·1MDIC·1
    1. 1
      ISO 14971
      Verified
      ISOiso.org
    2. 2
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org
    3. 3
      MDIC Case for Quality
      Verified
      MDICmdic.org

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