Medical Devices: Regulations, Standards and Practices (Woodhead Publishing Series in Biomaterials) - Hardcover

Ramakrishna, Seeram; Tian, Lingling; Wang, Charlene; Liao, Susan; Teo, Wee Eong

Hardcover

ISBN 10: 0081002890 ISBN 13: 9780081002896

Publisher: Woodhead Publishing, 2015

Synopsis

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

About this title

About the Authors

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.

From the Back Cover

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.

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.

Part One, covers the worldwide regulation of medical devices, management systems, standards for medical device manufacture, and the process of gaining approval for new medical devices. In addition, including recent changes to the regulations and standards.

In Part Two, we provide guidance on risk assessment procedures for new medical devices and safety and clinical testing based on 3 main ISO standards. Based on the latest version of those standards, we illustrate current standards and guidance documents.

In Part Three, we discuss the practices: product design overview, case studies and highlight the role of the international medical device regulator forum in the pursuit of global harmonization.

Professor Dr PE Seeram Ramakrishna, FREng, is the Director of Center for Nanofibers & Nanotechnology at the National University of Singapore and an Elected fellow Royal Academy of Engineering, UK; Institution of Engineers Singapore; and American Institute for Medical & Biological Engineering. Dr. Tian Lingling is a Research Fellow at National University of Singapore, Singapore. Ms. Charlene Wang has five years’ experience in biomedical research laboratory management. Dr. Susan Liao is Programme manager and Senior Research Fellow at Nanyang Technological University, Singapore. Mr Teo Wee Eong has over a decade of academic and industrial experience in medical devices ranging from single component implantable to electrical medical device. He is currently a senior product engineer responsible for ensuring compliance of medical devices.

Edition details

• Publisher: Woodhead Publishing
• Publication date: 2015
• Language: English
• ISBN 10: 0081002890
• ISBN 13: 9780081002896
• Binding: Hardcover
• Number of pages: 256