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Exam Name: Regulatory Affairs Certification (RAC) Global Scope
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Last Update: 2017-04-04
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NO.1 Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of
risk control
activities for a medical device?
A. Fishbone analysis
B. Quality by design analysis
C. Fault tree analysis
D. Failure modes, effects, and criticality analysis
Answer: D
NO.2 A regulation change is imminent and may require further non-clinical testing on a product
currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
A. Inform the company's senior management and arrange an emergency meeting
B. Arrange for additional testing of the product at the testing facility.
C. Consult with the company's legal department regarding options.
D. Obtain a copy of the proposed regulation and analyze the impact.
Answer: D
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