DEVICE RAC EXAM QUESTIONS AND
ANSWERS | LATEST UPDATE |
2024/2025 | 100% PASS
What is the primary purpose of regulatory affairs in the medical device industry?
A) To market devices effectively
B) To ensure devices are safe and effective for public use
C) To manage device recalls
D) To desi...
DEVICE RAC EXAM QUESTIONS AND
ANSWERS | LATEST UPDATE |
2024/2025 | 100% PASS
What is the primary purpose of regulatory affairs in the medical device industry?
A) To market devices effectively
B) To ensure devices are safe and effective for public use
✔✔C) To manage device recalls
D) To design new medical devices
Which regulatory body oversees the approval of medical devices in the United States?
A) Federal Trade Commission (FTC)
✔✔B) Food and Drug Administration (FDA)
C) Centers for Disease Control and Prevention (CDC)
D) National Institutes of Health (NIH)
What is a 510(k) submission?
A) A post-market surveillance report
1
,✔✔B) A premarket submission to demonstrate substantial equivalence to a legally marketed
device
C) A clinical trial protocol
D) An annual quality audit report
What does ISO 13485 pertain to?
A) Risk management for medical devices
B) Clinical trial protocols
✔✔C) Quality management systems for the design and manufacture of medical devices
D) Environmental impact assessments
What is the focus of ISO 14971?
✔✔A) Risk management for medical devices
B) Clinical evaluation
C) Quality assurance in manufacturing
D) Market access strategies
In the context of clinical trials, what does the term "informed consent" mean?
2
,A) Participants can withdraw at any time
✔✔B) Participants must be fully informed and voluntarily agree to participate
C) Consent forms must be signed by a lawyer
D) Participants are not allowed to discuss the trial with others
What is the primary goal of post-market surveillance?
A) To advertise the device
B) To train healthcare professionals
✔✔C) To monitor the safety and effectiveness of a device after market release
D) To conduct clinical trials
Which document outlines the regulations for good manufacturing practices (GMP)?
A) ISO 9001
✔✔B) 21 CFR Part 820
C) ISO 13485
D) 21 CFR Part 11
What is the significance of labeling in the medical device sector?
3
, A) Labels are optional
✔✔B) Labels provide critical information regarding use, risks, and instructions
C) Labels are only for marketing purposes
D) Labels must be in multiple languages
What does the term "adverse event" refer to?
A) A successful product launch
B) Positive feedback from users
✔✔C) Any undesirable experience associated with the use of a medical device
D) Routine maintenance
Which of the following is a key element of a Quality Management System (QMS)?
A) Marketing strategies
B) Financial reports
✔✔C) Document control
D) Sales training
What is the role of a regulatory affairs professional during the product development phase?
4
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