Edited by Stephen F. Amato, Principal Advisor, with Support from Robert Ezzell, PhD.
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