Validation for Medical Device and Diagnostic Manufacturers
Carol V. Desain, Charmaine V. Sutton
Inbunden, 1997
3 836 kr
Validation for Medical Device and Diagnostic Manufacturers
AvCharmaine V. Sutton,Carol V. Desain
E-bok
Engelska, 19973 818 kr
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Beskrivning
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
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