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KATEGORIE: QUALITY SYSTEMS
Design-Verifizierung
Bestätigung durch Prüfung und Nachweis, dass Design-Outputs die Design-Input-Anforderungen erfüllen.
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
- Trace each design input to verification methods (test, inspection, analysis).
- Execute protocols with predefined acceptance criteria.
- Handle failures via design change and re-verification.
- 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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