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tn58 started the topic Validate or Not in the forum Device Documentation 8 years, 1 month ago
As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your device or product to go off market through an MDR.
Suppose you start a medical device company with a partner, how would you manage to understand the validation processes of the products or devices your company plans to launch on the market? How will you manage your employees and make sure they understand what the company you started wants as far as validation processes goes? Please share your experiences.