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类别: QUALITY SYSTEMS
设计验证
通过检查和提供客观证据确认设计输出满足设计输入要求。验证回答"我们是否正确构建了产品？"——通常通过测试、检查和分析。
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.
RELATED GUIDES & TOOLS
SOURCES
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