Practical Design Control Implementation for Medical Devices by H.Burnham Kirkland
Author: H.Burnham Kirkland
Page Count: 232 pages
Published Date: 12 Mar 2003
Publisher: Taylor & Francis Inc
Publication Country: Boca Raton, FL, United States
Language: English
ISBN: 9781574911275
File Name: practical.design.control.implementation.for.medical.devices.pdf
Download Link: practical design control implementation for medical devices
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Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.
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