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Six Sigma for Medical Device Design by Jose Justiniano and Venky Gopalaswamy_1

Đối với thiết kế của các thiết bị y tế, FDA và các yêu cầu theo tiêu chuẩn ISO là cực kỳ nghiêm ngặt. Thiết kế và các nhà nghiên cứu cảm thấy áp lực từ quản lý để nhanh chóng phát triển các thiết bị mới, trong khi họ đồng thời cản trở bởi những hướng dẫn nghiêm ngặt. Six Sigma Triết lý này đã giải quyết mô hình lưỡng phân này cho các tổ chức trong các lĩnh vực khác, và tìm cách làm tương tự cho lĩnh vực thiết bị y tế | Six Sigma for Medical Device Design 2005 by CRC Press Six Sigma for Medical Device Design Jose Justiniano Venky Gopalaswamy CRC PRESS Boca Raton London New York Washington D.C. 2005 by CRC Press Library of Congress Cataloging-in-Publication Data Justiniano Jose M. Six Sigma for medical device design Jose Justiniano and Venky Gopalaswamy. p. cm. Includes bibliographical references and index. ISBN 0-8493-21o5-0 alk. paper 1. Medical instruments and apparatus Standards. 2. Six sigma Quality control standard I. Gopalaswamy Venky. II. Title. R856.6.J876 2004 610 .28 4--dc22 2004051971 This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means electronic or mechanical including photocopying microfilming and recording or by any information storage or retrieval system without prior permission in writing from the publisher. The consent of CRC Press does not extend to copying for general distribution for promotion for creating new works or for resale. Specific permission must be obtained in writing from CRC Press for such copying. Direct all inquiries to CRC Press 2000 N.W. Corporate Blvd. Boca Raton Florida 33431. Trademark Notice Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. Visit the CRC Press Web site at www.crcpress.com 2005 by CRC Press No claim to original U.S. Government works International Standard Book Number 0-8493-2105-0 Library of Congress Card Number 2004051971 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed