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CATÉGORIE: QUALITY SYSTEMS

Vérification de conception

Confirmation par examen que les sorties de conception satisfont aux exigences d'entrée.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Verification confirms that design outputs meet design inputs (“did we build the device right?”). It is distinct from validation and is a core design control activity.

PROCESS / STEPS

  1. Trace each design input to verification methods (test, inspection, analysis).
  2. Execute protocols with predefined acceptance criteria.
  3. Handle failures via design change and re-verification.
  4. File results in the DHF with traceability matrices.

EXAMPLES

  • Dimensional inspection of a molded housing against drawings is verification; clinical study of intended use is validation.

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TERMES CONNEXES

Contrôles de conceptionValidation de conception