Medical Devices
：Regulations, Standards and Practices
( Woodhead Publishing Series in Biomaterials )
Publication subTitle ：Regulations, Standards and Practices
Publication series ：Woodhead Publishing Series in Biomaterials
Author： Ramakrishna Seeram;Tian Lingling;Wang Charlene
Publisher： Elsevier Science
Publication year： 2015
E-ISBN: 9780081002919
P-ISBN(Paperback): 9780081002896
Subject： R318.1 artificial organs and organ
Keyword： 基础医学
Language： ENG
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Description
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