-
andria93 replied to the topic Design verification vs design validation in the forum Project Management Process and Medical Device Development 7 years, 3 months ago
Design Verification is focused more on paperwork stage of the project preparation. I will include all design imputs: specification, industrial regulations, and any important information regard to project planning and live document such DID. And you compare it against your output such as drawing, design specification, special testing, etc. The obvious importance of this step is to make sure that the design has not missed addressing any requirements. However, Validation is when you have an actual build of the product and run test against requirements of verification. so, you can think about it as engineering model to approve the concept for mass production after passing the verification and validation testing.