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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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Amato, Stephen F. (Editor ), Ezzell, Robert M., Jr (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cambridge, England : Woodhead Publishing, 2015.
Colección:Woodhead Publishing series in biomaterials ; no. 79.
Temas:
Acceso en línea:Texto completo
Descripción
Sumario: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.
Descripción Física:1 online resource (203 pages) : illustrations
Bibliografía:Includes bibliographical references at the end of each chapters and index.
ISBN:9780857099204
0857099205