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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 procedu...

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Bibliographic Details
Call Number:Libro Electrónico
Other Authors: Amato, Stephen F. (Editor), Ezzell, Robert M., Jr (Editor)
Format: Electronic eBook
Language:Inglés
Published: Cambridge, England : Woodhead Publishing, 2015.
Series:Woodhead Publishing series in biomaterials ; no. 79.
Subjects:
Online Access:Texto completo
Description
Summary: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 devicesEspecially useful for smaller companies who may not emplo.
Physical Description:1 online resource (203 pages) : illustrations
Bibliography:Includes bibliographical references at the end of each chapters and index.
ISBN:9780857099204
0857099205