Your Software/IVD clinical report is completely WRONG!
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices.
You may have made also this mistake and it would be better to know that before your Notified Body rejects your application.
You will understand how to solve that and get some advice from Cesare.
Who is Cesare Magri?
Cesare has a mixed Background: Physics and Neuroscience, Ph.D. in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices.
Links
- Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri-92465345/
- Be-on-Clinical LinkedIn Company: https://www.linkedin.com/company/be-on-clinical/about/
2 Replies to “Your Software/IVD clinical report is completely WRONG!”
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Do the notified bodies have guide lines of clical testing requirements as to what will be acceptable for submissions
This guidance is the one to look at https://ec.europa.eu/docsroom/documents/40323/attachments/1/translations/en/renditions/native