Overview

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 employ a full time vigilance professionalFocuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Full Product Details

9781322270982

Table of Contents

Reviews

Author Information

Stephen Amato is a member of the faculty teaching in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program at Northeastern University, Massachusetts. His research interests include U.S. and international product commercialization, FDA and global regulation, regulatory reimbursement, and the pricing of life sciences products. Bob Ezzell is a Graduate Instructor in Northeastern University's Regulatory Affairs Graduate Program, Massachusetts.

Tab Content 6

Customer Reviews

Recent Reviews

Countries Available