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>> View Table of Contents>> Author Acknowledgments
This critical resource includes all the medical device chapters from RAPS’ four Fundamentals of Regulatory Affairs books, covering the US, EU, Canada, and international. This highly focused compilation looks in-depth at requirements throughout the product lifecycle, from development through postmarketing. It is an excellent guide to finding answers on medical device regulations, learning about the industry, and as a study tool for the RAC (Device) Exam.
Here's what you get in the Fourth Edition:
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Studying for the RAC? Take a look at our RAC prep resources. Important note: while the Fundamentals books contain information on Canadian regulations, there are no Canada-specific questions on the RAC exams.
Published by RAPS © 2021. Hardcover. 844 pages. ISBN: 978-1-947493-67-4.