Main 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.

Contents:

1 Introduction

Part One

2 General regulations of medical devices

3 Quality management systems for medical device manufacture

4 The process of gaining approval for new medical devices

Part Two

5 Risk assessment and management for a new medical device

6 Safety testing of a new medical device

7 Clinical testing of a new medical device

8 Product development overview

Part Three

9 Case study: Successful development and approval of a new medical device

10 Global harmonization of medical devices