Regulatory affairs for biomaterials and medical devices / edited by Stephen F. Amato and Robert M. Ezzell Jr. ; contributors S. F. Amato [and ten others].
Material type:
TextSeries: Woodhead Publishing series in biomaterials ; Number 79.Publisher: Cambridge, England : Woodhead Publishing, 2015Copyright date: ©2015Description: 1 online resource (203 pages) : illustrationsContent type: - text
- computer
- online resource
- 9780857099204 (e-book)
- 344.041 23
- K3611.M45 .R448 2015
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Kandy | Available | KDEBRA1000484 |
Enhanced descriptions from Syndetics:
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
Includes bibliographical references at the end of each chapters and index.
Description based on print version record.
Electronic reproduction. Ann Arbor, MI : ProQuest, 2015. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
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