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
Table of Contents
1 IntroductionPart One2 General regulations of medical devices3 Quality management systems for medical device manufacture4 The process of gaining approval for new medical devicesPart Two5 Risk assessment and management for a new medical device6 Safety testing of a new medical device7 Clinical testing of a new medical device8 Product development overviewPart Three9 Case study: Successful development and approval of a new medical device10 Global harmonization of medical devices
