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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...
| Cote: | Libro Electrónico |
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| Autres auteurs: | , |
| Format: | Électronique eBook |
| Langue: | Inglés |
| Publié: |
Cambridge, England :
Woodhead Publishing,
2015.
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| Collection: | Woodhead Publishing series in biomaterials ;
no. 79. |
| Sujets: | |
| Accès en ligne: | Texto completo |
| Résumé: | 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. |
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| Description matérielle: | 1 online resource (203 pages) : illustrations |
| Bibliographie: | Includes bibliographical references at the end of each chapters and index. |
| ISBN: | 9780857099204 0857099205 |