The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
glossary
Use error
An act or omission of an act that results in a different medical device response than intended by the manufacturer…
glossary
Unanticipated Serious Adverse Device Effect (USADE)
A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not been identified in the current…
glossary
Unanticipated death or unanticipated serious injury
A death or serious injury is considered unanticipated if the condition leading to the event was not considered in a risk…
glossary
Unanticipated Adverse Device Effect (UADE)
Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a…
glossary
Trend reporting
A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred…
glossary
Summary of product characteristics (SmPC)
Part of the marketing authorization of a medicinal product setting out the agreed position of the product as distilled during the…
glossary
Significant risk device
An investigational device that: Is intended as an implant and presents a potential for serious risk to the health, safety,…
glossary
Signal
Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a…
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