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CATEGORY: QUALITY SYSTEMS
Design Controls
A set of practices and procedures embedded in the design process to ensure medical device design outputs meet design inputs. Required by FDA 21 CFR 820.30 and ISO 13485, covering design planning, inputs, outputs, reviews, verification, validation, and transfer.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Design Controls across 27 authorities in real time.
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