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类别: QUALITY SYSTEMS
设计控制
嵌入设计过程的一套实践和程序，确保医疗器械设计输出满足设计输入。FDA 21 CFR 820.30和ISO 13485要求，涵盖设计策划、输入、输出、评审、验证、确认和转移。
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
Design controls (e.g., 21 CFR 820.30 / ISO 13485 design & development) ensure design outputs meet inputs through planning, review, V&V, transfer, and changes.
PROCESS / STEPS
- Plan design stages and responsibilities.
- Document inputs/outputs and design reviews.
- Verify and validate against user needs and risks.
- Transfer to production; control design changes.
EXAMPLES
- DHF holds the living evidence of design control activities.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 设计控制 across 27 authorities in real time.
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