Sample Peer Reviewed Publications
Regulatory Affairs for Biomaterials and Medical Devices
Edited by Stephen F. Amato, Principal Advisor, with Support from Robert Ezzell, PhD.
Ordering Info:
Hardcover ISBN: 9780857095428
eBook ISBN: 9780857099204
All biomaterials utilized in regulated medical devices are subject to an extensive list of regulatory compliance requirements and standards. This edition provides readers with information on such requirements and standards in place in the US, as well as several geographic areas throughout the world. Individual chapters focus on a series of procedures and policies for these types of healthcare products such as including regulatory compliance, clinical development requirements , GxP's, and post-market surveillance
Key Features
- 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 authorization, university patent licenses and general good practice manufacturing