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Regulatory Affairs for Biomaterials and Medical Devices

Uncategorized Stephen Amato; Bob Ezzell 24 19th Mar, 2023

pdf 4.15 MB

Overview

All biomaterials and medical devices are subject to a long list of regulatory practices and policies that 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 procedures and policies including topics such as commercialization, clinical development, general good practice manufacturing, and post market surveillance.

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