Medical devices : regulations, standards and practices

✍ Scribed by Liao, Susan; Ramakrishna, Seeram; Teo, Wee Eong; Tian, Lingling; Wang, Charlene

Publisher: Woodhead Publishing
Year: 2015
Tongue: English
Leaves: 253
Series: Woodhead Publishing series in biomaterials number 103
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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 Read more...

Abstract: 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

✦ Table of Contents

Content: ""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 States""""2.2.2. 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 China""""2.4.2. 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 820""""3.1.2. 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 countries""""3.2.5.1. 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)""

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