Real World Evidence (RWE) is the evidence derived from the analysis and/or synthesis of real-world data (RWD).
Other glossary definitions
I
Incident for Medical Device (MEDDEV definition)
Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due…
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S
Significant risk device
An investigational device that: Is intended as an implant and presents a potential for serious…
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