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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:
To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Discount is only available when purchasing both versions in the same transaction.
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. E-book. 844 pages. ISBN: 978-1-947493-68-1.