These questions test the knowledge of LSI's Medical Device Report (MDR) Handling (D000552).
United States of America
Canada
Australia
European Economic Area, including Switzerland and Turkey
New Zealand
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Within 30 days of becoming aware of the event
Within 48 hours of becoming aware of the event
Within 10 calendar days of becoming aware of the event
Within 7 calendar days of becoming aware of the event
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May have caused or contributed to a death or serious injury
Malfunctions not likely to result in death or serious injury
Malfunctions of the device, or similar device marketed by the manufacturer or importer would be likely to cause death or serious injury if the malfunction were to recur
A product review of one of our devices is found posted on social media
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The number of devices on the market
Reportable Incidents
Incidents that are typically exempt from reporting
Events that are not considered reportable
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Quiz Review Timeline (Updated): Mar 20, 2023 +
Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.
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