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.
Weiterführende Informationen
Personen: Amato, Stephan F.
XC 4000 A488-01
Amato, Stephan F.:
Regulatory affairs for biomaterials and medical devices / edited by Stephen F. Amato and Robert M. Ezzell Jr. - Amsterdam : Woodhead Publishing, 2015. - XV, 185 Seiten : Illustrationen. - (Woodhead Publishing series in biomaterials; number 79)
ISBN 978-0-85709-542-8
Allgemeine Medizin - Buch