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Medical Device Reporting

Welcome to your Medical Device Reporting Quiz

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1. Which of the following products ARE FDA ­ regulated medical devices?
2. Which of the following is NOT true about the premarket review of medical devices?
3. Which of the following statements emphasizes the importance of post market surveillance by healthcare professionals?
4. Which of the following is NOT considered one of the three broad categories of medical device adverse events?
5. Which of the following is NOT a device user facility?
6. Which of the following is NOT a reportable event under MDR?
7. Which of the following IS true for healthcare professionals working in a device user facility?
8. Which of the following incidents must be reported by the user facility under MDR?
9. Which of the following device reports would NOT be of interest to FDA?
10. Which of the following statements is NOT true?
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