Validation for Medical Device and Diagnostic Manufacturers
Book Details
Format
Hardback or Cased Book
ISBN-10
1574910639
ISBN-13
9781574910636
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Sep 30th, 1997
Print length
336 Pages
Weight
658 grams
Product Classification:
Medicine: general issues
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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.
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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