Validation for Medical Device and Diagnostic Manufacturers: 2nd Edition (Hardback) book cover

Validation for Medical Device and Diagnostic Manufacturers

2nd Edition

By Carol V. Desain, Charmaine V. Sutton

CRC Press

336 pages

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Hardback: 9781574910636
pub: 1997-09-30
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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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical