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: 231
Series: Woodhead Publishing series in biomaterials number 103
Edition: 1
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 international regulatory requirements and standards.

Provides readers with a global perspective on medical device regulations
Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards
Includes a useful case study demonstrating the design and approval process

✦ Table of Contents

Content:
Front Matter,Copyright,List of contributors,Woodhead Publishing Series in BiomaterialsEntitled to full text1 - Introduction, Pages 1-17
2 - General regulations of medical devices, Pages 21-47
3 - Quality management systems for medical device manufacture, Pages 49-63
4 - The process of gaining approval for new medical devices, Pages 65-119
5 - Risk assessment management for a new medical device, Pages 123-135
6 - Safety testing of a new medical device, Pages 137-153
7 - Clinical testing of a new medical device, Pages 155-173
8 - Product development overview, Pages 177-188
9 - Case study: successful development and approval of a new medical device, Pages 189-206
10 - Global harmonization of medical devices, Pages 207-213
References, Pages 215-229
Index, Pages 231-236

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