The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:
|unanticipated serious adverse device effect - USADE||
A unanticipated serious adverse device efect (USADE) is a serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
A user describes the person, who can either be a healthcare professional or lay person using the device.