Regulatory Affairs for Biomaterials and Medical Devices

Nonfiction, Health & Well Being, Medical, Reference, Instruments & Supplies, Science & Nature, Technology, Engineering
Cover of the book Regulatory Affairs for Biomaterials and Medical Devices by , Elsevier Science
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Author: ISBN: 9780857099204
Publisher: Elsevier Science Publication: October 27, 2014
Imprint: Woodhead Publishing Language: English
Author:
ISBN: 9780857099204
Publisher: Elsevier Science
Publication: October 27, 2014
Imprint: Woodhead Publishing
Language: English

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.

  • Addresses global regulations and regulatory issues surrounding biomaterials and medical devices
  • Especially useful for smaller companies who may not employ a full time vigilance professional
  • Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
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All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.

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