Medical devices : regulations, standards and practices

Publication Data

• Title Medical devices : regulations, standards and practices
• Author Seeram Ramakrishna
• Contributors Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo
• Publisher Woodhead Publishing
• Publication date 2015
• Publication location Oxford
• Language English

Contents

1 Introduction

2 General regulations of medical devices

3 Quality management systems for medical device manufacture

4 The process of gaining approval for new medical devices

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

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

10 Global harmonization of medical devices

Topics

• Medical instruments and apparatus
• 017438604

Medical devices : regulations, standards and practices by Seeram Ramakrishna. ISBN 9780081002919. Published by Woodhead Publishing in 2015. Publication and catalogue information, links to buy online and reader comments.