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
Clinical Impact
The effect that something is likely to have on the treatment of a particular group of people, or on the…
Clinical Evaluation Report (CER)
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of…
CE-Marking Technical File
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification…
CE Marking
CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable…
Value Proposition
The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where…
Target Product Profile (TPP)
Target product profile (TPP) in the US A TPP can be prepared by a sponsor and then shared with the…
Safety Data Exchange Agreement (SDEA)
A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product…
Real World Data (RWD)
An umbrella term for data regarding the effects of health interventions (e.g. safety, effectiveness, resource use, etc) that are not…