All terms
Quality & RiskQuality System
Design Controls
Structured process governing the design of medical devices.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Design controls (21 CFR 820.30) are an interrelated set of practices and procedures that are incorporated into the design and development process to manage design inputs, outputs, verification, validation, transfer, and changes.What this means in practice
Design controls are required for almost all Class II and Class III devices and for select Class I devices. They form the audit trail used by FDA, Notified Bodies, and internal auditors to evaluate design quality.Cross-references
Part of
A larger framework or document this term belongs to.
Contains
Sub-elements or required artefacts of this term.
Precedes
Comes before in a typical workflow or lifecycle.
Primary references
3 sourcesLink health: 2 verified 1 needs review· last checked 2026-05-09
eCFR·1ISO·1AAMI·1
- 1
21 CFR 820.30 Design ControlsNeeds revieweCFRecfr.gov
- 2
ISO 13485 Standard PageVerifiedISOiso.org
- 3
AAMI - Quality Systems ResourcesVerifiedAAMIaami.org
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