Pre-Production Quality Assurance for Healthcare Manufacturers

1st Edition

G. William Hough, David A. Rawlings, Michael F. Turner

CRC Press
Published June 30, 1997
Reference - 292 Pages
ISBN 9781574910452 - CAT# PH0450

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Summary

The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.

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