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Fady Khalla replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 11 months ago
This is a very common question in the medical device industry. The best way to look at it is to understand the definition of both Verification and Validation.
From 21 CFR 820:
– Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)
– Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.In Simple words: Verification is to verify that you have made the device correctly according to your specification.
Validation is that you have made the device that the customer needs.Design verification usually includes bench testing and lab testing to verify that your output meets your specifications.
Design Validation usually includes clinical studies and Human factor testing to verify that you made the device that the user needs.
Hope that helps,
Fady