Seeram Ramakrishna, Lingling Tian, Charlene Wang

Medical Devices

Regulations, Standards and Practices

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Woodhead Publishing Series in Biomaterials
• Verlag: Elsevier Science & Technology / Woodhead Publishing
• Artikelnr. des Verlages: C2014-0-02797-9
• Seitenzahl: 256
• Erscheinungstermin: 10. Dezember 2015
• Englisch
• Abmessung: 236mm x 151mm x 20mm
• Gewicht: 513g
• ISBN-13: 9780081002896
• ISBN-10: 0081002890
• Artikelnr.: 42767834

Autorenporträt

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.

Inhaltsangabe

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