類別: QUALITY SYSTEMS

設計確認

確認器材在實際或模擬使用條件下滿足用戶需求和預期用途。確認回答"我們是否構建了正確的產品？"——通常透過臨床評價和模擬使用測試。

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

Validation confirms that devices meet user needs and intended uses (“did we build the right device?”). Includes design validation, process validation, software validation, and sterilization validation as applicable.

PROCESS / STEPS

Define intended use and user needs as validation reference points.
Select methods: simulated use, clinical evaluation, process PQ, software system testing.
Use production-equivalent units under expected conditions.
Document residual risks and limitations of validation evidence.

EXAMPLES

Software system tests against user workflows and clinical validation of diagnostic accuracy are both validation activities.

RELATED GUIDES & TOOLS

SOURCES

FDA design controls / process validation concepts ↗

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