Developed by established regulatory experts, each Fundamentals book provides a comprehensive understanding of the most current regulatory requirements across product lines. They break down complex regulations into simple language, with versions for the US, Canada, EU and Japan, as well as an International edition.
Fundamentals are used by more than a dozen universities as a required text, some of the largest healthcare organizations as a staple in each employee’s office and Regulatory Affairs Certification (RAC) Exam takers as a key study tool.
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We also offer Global Medical Device Regulations —a compilation of chapters covering medical device regulation, adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series.
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