Design Verification and Validation

Design Verification and Validation (V&V) are the formal activities used to prove that a product is built correctly and works for its intended use. 
 
FDA 21 CFR 820.30 requires verification to confirm that design outputs meet design inputs, and validation to confirm the final device meets user needs and intended use, including use under actual or simulated conditions. ISO 13485 mirrors these requirements as part of design and development controls. 
 
Simple distinction: 
 
Verification: Did we design it right? 
 
Validation: Did we design the right thing? 
 
Why it matters: weak V&V is a leading cause of recalls, safety issues, and regulatory rejection.