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kmt29 replied to the topic When is validation is not required? in the forum Introduction to Design Controls 8 years, 6 months ago
I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the quality of the product. Also, the evaluation can show if the product can be a good use to the human body. Just think about if there is no evaluation is not completed the device can be harmful for patients. The link below is an article that was written by ASME that breaks down Validation and Verification for Medical Devices. One of the things I found interesting was that it gives answers to question that you may have about Validation and Verification.
https://www.asme.org/engineering-topics/articles/manufacturing-design/validation-verification-for-medical-devices