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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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Purchase the Fundamentals of Medical Device Regulations and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC Exam Takers: Experience and other knowledge play a significant role in your preparation and ability to pass the exam. Please consider these materials as reference guides and not your sole preparation for the exam. A good first step in your preparation is to carefully review the RAC (Device) Content Outline (PDF).
Please note: After purchasing your practice test, you can access them through the RAPS Learning Portal. You will have access to the practice test for one full year and may take it as often as you like.
Also available for purchase with the hardcover version.
Important note: RAC Exam questions are updated after the Spring testing cycle every year to reflect current regulations, guidelines and practice. New examination content is added before the Summer testing cycle and covers regulations in effect as of 31 December of the previous year.
This fourth edition book is the most up-to-date version currently available for RAC preparation purposes. The next revised edition of Fundamentals of Medical Device Regulations is scheduled to be released May 2022. While the Fundamentals books contain information on Canadian regulations, there are no Canada-specific questions on the RAC exams. You can view the RAC exam sections and content here.
Neither RAPS nor the RAC Program states or implies that preparation material provided by RAPS is the best or only means of adequately preparing for the RAC examination. No advantage is given to candidates who purchase or use RAC preparation material provided by RAPS over candidates who prepare using other materials and/or methods. The use and purchase of preparation courses and materials from RAPS is optional.