
Medical Device Approval
Quiz by Diana Sima
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8 questions
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- Q1Define the QMS acronym:Quality Manufacturing SystemQuality Management SystemQuantitative Measuring SoftwareQuality Monitoring Service30s
- Q2Does a CE mark guarantee that a device is safe?YesNo30s
- Q3What is a "corrective action"?fixing a problem that occurredfix a common root cause for problems that might occur, but did not yet occurfixing the root cause of a problem that occurred30s
- Q4What is the risk class of an MR scanner in the US?lowhighmoderate30s
- Q5Who performs medical device testing?FDAnobodyNotified Bodythe manufacturer of the device30s
- Q6Can a Notified Body perform an unannounced audit in a company that already received a QMS certificate?NoYes30s
- Q7Does FDA require informing the user about accuracy and reproducibility of your software, if your software has a measuring function?NoYes30s
- Q8Is 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