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Post Market Surveillance consists of 2 elements, the reactive and the proactive, as such Vigilance is a vital element Post Market Surveillance activities which directly feeds critical data for device safety and through its assessment in the clinical evaluation process can lead to design changes through risk evaluation.
The EU/MDR requirements added an extreme layer of effort and scrutiny to vigilance data as a source of safety and performance evidence.
Today, all manufacturers are struggling to keep up with the sheer amount of vigilance data that must be created yearly.
Through our daily efforts producing Vigilance Search Reports we developed EVA to streamline and strengthen the data output, surveillance and analysis and situational awareness.
EVA was designed as a vigilance data fusion tool able to perform real time data
Extraction from parallel searches in databases worldwide
Analysis with unified search terms an filtering
Presentation of data through intuitive user interface
Contact us at info@evnia.dk to discover how EVA can facilitate your Vigilance efforts