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CATEGORY: QUALITY SYSTEMS
Design Verification
Confirmation by examination and provision of objective evidence that design outputs meet design input requirements. Verification answers "Did we build the product right?" — typically through testing, inspection, and analysis.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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SOURCES
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