RAC Exam RAC Exam

RAC Devices Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
RAC Devices Examination Autumn 2022
Application Deadline: 6 October 2022 (11:59 PM EDT)
  
Knowledge Required and Regulatory Basis: 
  • Knowledge of the full product development and lifecycle requirements for medical devices, and IVDs.
  • Knowledge of US FDA requirements (30%); European regulations and guidances from the European Commission and competent authorities (30%); and globally applicable regulatory practices* (40%). (WHO and ISO guidelines and standards).
  • Critical thinking and analytical skills.
Best Suited For: 
Medical device and IVD regulatory professionals with 3+ years of experience. Experience should include hands-on regulatory activities, knowledge of interaction with regulatory authorities, and appreciation of regulatory involvement throughout the entire product development and lifecycle. 

Notice: 
Please verify that the email address in your RAPS account is correct. At that email address, you will receive your notification to schedule (NTS) email from our testing vendor, CASTLE. The NTS email provides login information necessary to access the CASTLE website, where you will request your preferred exam date, time and location.

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