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portada validation for medical device and diagnostic manufacturers
Type
Physical Book
Author
Publisher
Year
1997
Language
English
Pages
336
Format
Hardcover
Dimensions
24.0 x 15.2 x 2.3 cm
Weight
0.65 kg.
ISBN
1574910639
ISBN13
9781574910636
Edition No.
0002
Categories

validation for medical device and diagnostic manufacturers

Carol V. Desain (Author) · Charmaine V. Sutton (Author) · CRC Press · Hardcover

validation for medical device and diagnostic manufacturers - Desain, Carol V. ; Sutton, Charmaine V.

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Synopsis "validation for medical device and diagnostic manufacturers"

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 determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

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