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Medical Devices

Regulations, Standards and Practices

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Auteur(s): Ramakrishna, Seeram

Tian, Lingling

Wang, Charlene

Editeur: Elsevier Science

Année de Publication: 2015

pages: 253

ISBN: 978-0-08-100289-6

eISBN: 978-0-08-100291-9

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

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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