EVA
Evnia Vigilance Algorithm
our automated vigilance algorithm scans, analyses and reports safety and performance incidents from multiple vigilance databases on real time!
The purpose of the Medical Device Vigilance Systems is to enable the collection, assessment, reporting and identification of potential trends in incidents resulting from the real-world use of medical devices.
According to the European Commission, the purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
EVA – is an automated and validated algorithm using web scraping to:
Scan
Extract
Analyse
Provide Graphical Analysis
of multiple vigilance databases on a real time basis thus providing a cost and time efficient way to collect vigilance data for reporting.
The large number of national vigilance databases worldwide does not always facilitate the timely identification and recording of performance/safety incidents. Eva has been designed to support manufacturers comply with the European vigilance reporting requirements under MDR/IVDR but can also support remediation efforts and gap analyses of manufacturers worldwide!
EVA is currently supporting FDA, UK-MHRA, BfArM, Health Canada but can be adapted and customised to serve additional databases if required.
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