Validation for Medical Device and Diagnostic Manufacturers  book cover
2nd Edition

Validation for Medical Device and Diagnostic Manufacturers

ISBN 9781574910636
Published September 30, 1997 by CRC Press
336 Pages

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Book 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.

Table of Contents

Introduction to Quality Systems
Validation Overview
Product Development & Validation
Validation Study Plans, Protocols, Reports
Process Development & Validation
Test Method Development & Validation
Qualification of Equipment & Equipment Systems
Qualification of Software-Driven, Automated Equipment & Equipment Systems
Facility Qualification Studies
Validation Studies at Suppliers & Contractors
Change Management for Validated Products, Processes, & Methods
Revalidation & Requalification Studies
Supporting Appendices

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