KATEGORIE: QUALITY SYSTEMS

Design Controls

Praktiken und Verfahren im Designprozess, die sicherstellen, dass Design-Outputs die Design-Inputs erfüllen. Erforderlich nach FDA 21 CFR 820.30 und 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

FDA Design Control guidance ↗

Track regulatory signals related to Design Controls across 27 authorities in real time.

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