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類別: QUALITY SYSTEMS
設計驗證
透過檢查和提供客觀證據確認設計輸出滿足設計輸入要求。驗證回答"我們是否正確構建了產品？"——通常透過測試、檢查和分析。
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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SOURCES
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