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Validation for Medical Device and Diagnostic Manufacturers, Second Edition

Description: 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.

Price: 205 USD

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End Time: 2024-11-06T01:06:44.000Z

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Validation for Medical Device and Diagnostic Manufacturers, Second EditionValidation for Medical Device and Diagnostic Manufacturers, Second EditionValidation for Medical Device and Diagnostic Manufacturers, Second Edition

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Return shipping will be paid by: Buyer

All returns accepted: Returns Accepted

Item must be returned within: 60 Days

Refund will be given as: Money Back

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EAN: 9781574910636

UPC: 9781574910636

ISBN: 9781574910636

MPN: N/A

Number of Pages: 336 Pages

Language: English

Publication Name: Validation for Medical Device and Diagnostic Manufacturers

Publisher: CRC Press LLC

Subject: Instruments & Supplies, Pharmacology, Diagnosis, Biomedical

Item Height: 0.9 in

Publication Year: 1997

Item Weight: 21.7 Oz

Type: Textbook

Item Length: 6 in

Subject Area: Technology & Engineering, Medical

Author: Carol V. Desain, Charmaine V. Sutton

Item Width: 9 in

Format: Hardcover

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