Title Medical devices : regulations, standards and practices / Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao and Wee Eong Teo

Published Cambridge : Woodhead Publishing, an imprint of Elsevier, [2015] ©2015

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Description 1 online resource : color illustrations Series Woodhead Publishing series in biomaterials ; number 103 Woodhead Publishing series in biomaterials ; no. 103. Contents Front Cover -- Medical Devices: Regulations, Standards and Practices -- Copyright -- Contents -- List of contributors -- Woodhead Publishing Series in Biomaterials -- Chapter 1: Introduction -- 1.1. Medical devices: definitions and types -- 1.2. Market trend -- 1.3. Safety issues -- 1.4. The development of regulations and standards -- 1.5. The structure of this book -- FAQs -- Part One: Regulations and standards -- Chapter 2: General regulations of medical devices -- 2.1. Introduction -- 2.2. The United States 2.2.1. The regulatory authority for medical devices and its organization in the United States2.2.2. Classification of medical devices and the relevant controls in the United States -- 2.2.3. Practical guide to identifying the medical devices classification in the United States -- 2.3. The European Union -- 2.3.1. Regulatory framework for medical devices in the EU -- 2.3.2. New changes in EU regulation -- 2.3.3. Differences between the regulations for medical devices in the United States and the EU -- 2.4. China 2.4.1. The regulatory framework for medical devices in China2.4.2. Changes in Chinese regulations -- 2.4.2.1. The evolution of CFDA -- 2.4.2.2. Revised regulation on the supervision and administration of medical devices -- 2.5. Japan -- 2.6. Australia -- 2.7. India -- 2.8. Singapore -- 2.8.1. Regulatory framework for medical devices in Singapore -- 2.8.2. Grouping of medical devices for production registration in Singapore -- 2.9. Conclusions -- FAQs -- Chapter 3: Quality management systems for medical device manufacture -- 3.1. Introduction 3.1.1. History of QSR 21 CFR 8203.1.2. History of ISO 13485 -- 3.2. ISO 13485:2012 -- 3.2.1. General requirements of ISO 13485: 2012 -- 3.2.2. Document control required by ISO 13485:2012 -- 3.2.2.1. Quality manual -- 3.2.2.2. Control of documents -- 3.2.2.3. Control of records -- 3.2.3. Processes required by ISO 13485 -- 3.2.3.1. Implementation -- 3.2.3.2. Process effectiveness -- 3.2.4. Conformity assessment, registration, and certification processes -- 3.2.4.1. Conformity assessment -- 3.2.4.2. Certification 3.2.5. ISO 13485 application in various countries3.2.5.1. EU -- 3.2.5.2. Canada -- 3.2.5.3. Japan -- 3.3. Current good manufacturing practice -- 3.4. The difference between ISO 13485 and cGMP -- 3.5. Conclusions -- FAQs -- Chapter 4: The process of gaining approval for new medical devices -- 4.1. Introduction -- 4.2. The United States -- 4.2.1. Step 1: Classify device -- 4.2.2. Step 2: Choose correct premarket submission -- 4.2.3. Step 3: Prepare documents for submission to the FDA -- 4.2.3.1. Class I process -- 4.2.3.2. Class II process-510(k) Summary Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards Bibliography Includes bibliographical references and index Notes Online resource; title from PDF title page (EBSCO, viewed August 21, 2015) Subject Medical instruments and apparatus. Surgical instruments and apparatus. Equipment and Supplies -- standards Equipment and Supplies Surgical Equipment Surgical Instruments HEALTH & FITNESS -- Holism. HEALTH & FITNESS -- Reference. MEDICAL -- Alternative Medicine. MEDICAL -- Atlases. MEDICAL -- Essays. MEDICAL -- Family & General Practice. MEDICAL -- Holistic Medicine. MEDICAL -- Osteopathy. Medical instruments and apparatus Surgical instruments and apparatus Form Electronic book Author Tian, Lingling, author Wang, Charlene, author Liao, Susan, author Teo, Wee Eong, author ISBN 9780081002919 0081002912

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