Fundamentals of Medical Device Regulations, Fifth Edition

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Fundamentals of Medical Device Regulations, Fifth Edition

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Table of Contents


Lead Editors

Gert Bos, MSc, PhD, FRAPS and Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices

Product Description

Fundamentals of Medical Device Regulations, Fifth Edition, is a compilation encompassing completely revised medical device and in vitro diagnostic (IVD) chapters from Fundamentals of US Regulatory Affairs, 11th Edition, and Fundamentals of EU Regulatory Affairs, Ninth Edition, in addition to the medical device and IVD chapters from Fundamentals of International Regulatory Affairs, Fifth Edition, updated in June 2021.

Who should buy this book?

Fundamentals of Medical Device Regulations, Fifth Edition was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant medical device regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on medical device regulations and policy worldwide.

This is an outstanding reference for individuals working in multinational product development and marketing at all levels, from seasoned regulatory personnel who need to check facts or are dealing with a new product type to those new to the profession. It also is a handy study tool for those planning to sit for the Regulatory Affairs Certification (RAC) exam, in addition to professional experience, training, and other resources.
Daniel G. Mannix, PhD
Chair, RAPS Editorial Advisory Committee

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Published by RAPS © 2021. Paperback. 240 pages. ISBN: 978-1-947493-61-2

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