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Out of the key regulations, what is mandatory adverse event reporting?


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Kinnek Community

A company must report any undesirable experience associated with the use of a medical product in a patient that results in: death, life threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (device), or other serious medical events requiring medical or surgical intervention 

Jan 29, 2016

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