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
Significant risk device
An investigational device that: Is intended as an implant and presents a potential for serious risk to the health, safety,…
Signal
Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a…
Serious incident (MDR definition)
Any incident that directly or indirectly led, might have led or might lead to any of the following: The death…
Serious (Public) Health Threat
Any event type, which results in an imminent risk to the study population of death, serious injury, or serious illness…
Serious Adverse Device Effect (SADE)
Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious Adverse Event.
Safety concern
An important identified risk, an important potential risk, or important missing information.
Risk minimization measure
Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to…
Risk-benefit balance
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating…