Adverse Event (AE)

Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users, or other persons whether or not related to the investigational (in vitro) medical device. This definition includes events related to the investigational device or the comparator and the events related to the procedures involved (any procedure in the clinical investigational plan). For users or other persons, this is restricted to events related to the investigational medical device.

Anticipated Serious Adverse Device Effect (ASADE): an effect which by its nature, incidence, severity, or outcome has been previously identified in the risk analysis report.


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