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CATÉGORIE: QUALITY SYSTEMS
Contrôles de conception
Un ensemble de pratiques et procédures intégrées au processus de conception pour garantir que les sorties de conception répondent aux entrées. Requis par FDA 21 CFR 820.30 et ISO 13485.
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
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