Medical Devices: Regulations, Standards and Practices

ISBN-13: 9780081002896 / Angielski / Twarda / 2015 / 256 str.

Ramakrishna, Seeram Tian, Lingling Teo, Wee Eong

Opis

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

Spis treści

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

O autorze

Seeram Ramakrishna is the Director of the Center for Nanofibres and Nanotechnology at the National University of Singapore (NUS), which is ranked among the top 20 universities in the world. He is regarded as the modern father of electrospinning. He is an elected Fellow of UK Royal Academy of Engineering (FREng); Singapore Academy of Engineering; Indian National Academy of Engineering; and ASEAN Academy of Engineering & Technology. He is an elected Fellow of the International Union of Societies of Biomaterials Science and Engineering (FBSE); Institution of Engineers Singapore; ISTE, India; Institution of Mechanical Engineers and Institute of Materials, Minerals & Mining, UK; and American Association of the Advancement of Science; ASM International; American Society for Mechanical Engineers; American Institute for Medical & Biological Engineering, USA. He is an editor of Elsevier journal Current Opinion in Biomedical Engineering. Dr. Tian Lingling is a Research Fellow at National University of Singapore, Singapore. She obtained her Ph.D in Textile Engineering from College of Textiles, Donghua University, Shanghai, China in March of 2014. Her research interests include fabrication of electrospun nanofibers and electrosprayed nano/micro-particles, and the application in cardiac, bone and nerve tissue engineering. She has around 10 peer-reviewed journal/conference paper/book chapter publications and one patent. Dr. Susan Liao is Programme manager and Senior Research Fellow at Nanyang Technological University, Singapore. She was Lee Kuan Yew Research Fellow in the Division of Bioengineering and Department of Orthopaedic Surgery, National University of Singapore. She obtained her Ph.D in Biomaterials from the Department of Materials Science and Engineering, Tsinghua University, Beijing, China. Her research interests include Tissue Engineering, Biomimetic nanomaterials, Biomineralization and Cell-biomimetic matrix reactions. She has around 80 peer-reviewed journal/book chapter publications and over 40 international conference presentations. She has also served as an editorial board member for four professional journals and as a reviewer for over forty professional journals.