类别: QUALITY SYSTEMS

设计确认

确认器械在实际或模拟使用条件下满足用户需求和预期用途。确认回答"我们是否构建了正确的产品？"——通常通过临床评价和模拟使用测试。

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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