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Dregs Couverture der - WHO

HEALTHCARE TECHNOLOGY LIFE CYCLE medical DEVICE. Marketing Transfer Distribution Manufacture Testing Development Research PROVISION. REGULATIONS. Assessment of needs Global overview and Technology assessment Evaluation Planning De-commissioning guiding principles Maintenance Procurement Training Installation Operation ACQUISITION Commissioning UTILISATION. DEPARTMENT OF BLOOD SAFETY AND CLINICAL TECHNOLOGY. WORLD HEALTH ORGANIZATION. 1211 GENEVA 27 92 4 154618 2. SWITZERLAND. Fax 41 22 791 4836. E-mail WORLD HEALTH ORGANIZATION. GENEVA. medical DEVICE. REGULATIONS. Global overview and guiding principles WORLD HEALTH ORGANIZATION. GENEVA. WHO Library Cataloguing-in-Publication Data World Health Organization. medical device regulations : global overview and guiding principles. and supplies legislation and supplies . standards making management control ISBN 92 4 154618 2 (NLM Classification: WA 26). Acknowledgements This guide was prepared under the principal authorship of Dr Michael Cheng.

Contents iii Foreword v Glossary vii Note on the definition of medical devices vii Chapter 1. Introduction 1 Chapter 2. Medical device safety 3 2.1 Medical device safety and risk management 3

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