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Medical Device Approval

Quiz by Diana Sima

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8 questions
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  • Q1
    Define the QMS acronym:
    Quality Manufacturing System
    Quality Management System
    Quantitative Measuring Software
    Quality Monitoring Service
    30s
  • Q2
    Does a CE mark guarantee that a device is safe?
    Yes
    No
    30s
  • Q3
    What is a "corrective action"?
    fixing a problem that occurred
    fix a common root cause for problems that might occur, but did not yet occur
    fixing the root cause of a problem that occurred
    30s
  • Q4
    What is the risk class of an MR scanner in the US?
    low
    high
    moderate
    30s
  • Q5
    Who performs medical device testing?
    FDA
    nobody
    Notified Body
    the manufacturer of the device
    30s
  • Q6
    Can a Notified Body perform an unannounced audit in a company that already received a QMS certificate?
    No
    Yes
    30s
  • Q7
    Does FDA require informing the user about accuracy and reproducibility of your software, if your software has a measuring function?
    No
    Yes
    30s
  • Q8
    Is it allowed to manufacture a medical device that has any risk for the patient?
    Yes, if it was tested on a large number of healthy volunteers.
    Yes, as long as the residual risks are acceptable and benefits outweigh these risks.
    No, no risk for the patients is allowed.
    30s

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