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Medical Devices: Regulations, Standards and Practices: Woodhead Publishing Series in Biomaterials

Autor Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo
en Limba Engleză Hardback – 4 sep 2015
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
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Specificații

ISBN-13: 9780081002896
ISBN-10: 0081002890
Pagini: 256
Dimensiuni: 152 x 229 x 18 mm
Greutate: 0.54 kg
Editura: ELSEVIER SCIENCE
Seria Woodhead Publishing Series in Biomaterials


Cuprins

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