Regulatory Affairs for Biomaterials and Medical Devices book cover

Regulatory Affairs for Biomaterials and Medical Devices

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.

Hardbound, 300 Pages

Published: October 2014

Imprint: Woodhead Publishing

ISBN: 978-0-85709-542-8

Contents

  • Historical overview and current situation; Technical aspects of biomaterial commercialization; Regulatory strategies for USA; Clinical development and endpoint strategies; Supply Chain Risk Management; Approval of devices and biomaterials; Good manufacturing practice; Vigilance procedures/post market surveillance; Regulatory Strategies in Asia; Continuing evolution of market access paradigms from a health policy perspective.

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