Validation for Medical Device and Diagnostic Manufacturers

Validation for Medical Device and Diagnostic Manufacturers
Author :
Publisher : Interpharm CRC
Total Pages : 301
Release :
ISBN-10 : 0935184643
ISBN-13 : 9780935184648
Rating : 4/5 (648 Downloads)

Book Synopsis Validation for Medical Device and Diagnostic Manufacturers by : Carol DeSain

Download or read book Validation for Medical Device and Diagnostic Manufacturers written by Carol DeSain and published by Interpharm CRC. This book was released on 1994-01-01 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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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