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Validation for Medical Device and Diagnostic Manufacturers Used & Rental Textbooks a visit to any bookstoreDescription Implementation of FDA's Design Control requirements (21 CFR 820. 30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods requirements specifications