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    Quality & RiskQuality SystemV&V

    Verification & Validation

    Confirming design outputs meet inputs (V) and that devices meet user needs (V).

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

    Definition

    Verification confirms by examination that specified requirements have been fulfilled (did we build the device right?). Validation confirms that requirements for a specific intended use can be consistently fulfilled (did we build the right device?).

    What this means in practice

    V&V plans, protocols, and reports are central artifacts in design controls and submissions. Software V&V follows IEC 62304.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·2MDIC·1
    1. 1
      FDA Design Control Guidance
      Needs review
      FDAfda.gov
    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.