Regulatory Affairs for Biomaterials and Medical Devices

Regulatory Affairs for Biomaterials and Medical Devices

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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. 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... to a standard submission whereby the complete ISO 13485 Standard Operating Procedures (SOPs), quality manual, ... of Technical Documentation ( STED) published in the former GHTF format is acceptable in most Asian countries : Honganbsp;...

Title:Regulatory Affairs for Biomaterials and Medical Devices
Author:Stephen F. Amato, Robert M. Ezzell Jr
Publisher:Elsevier - 2014-10-27


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