Vigilance data can support a medical device throughout its lifecycle and is one of the most useful real-world data sources.
With that in mind, are you looking for a Medical Device Vigilance Service that will enable the comprehensive collection, assessment, and reporting of vigilance data based on the real-world use of medical devices?
Evnia has the right tool!
EVA, our vigilance algorithm, scans, analyses, and reports safety and performance incidents from multiple vigilance databases!
EVA has been designed to support clinical evaluations but also remediation tasks and gap analyses for international regulatory needs!
EVA is currently supporting
👉 FDA’s databases MAUDE, and TPLC
👉 UK’s #MHRA
👉 Germany’s BfArM, and
👉 Canada’s Health Canada | Santé Canada
but can serve additional databases upon request!
Read more: Vigilance EVA algorithm
