[WEBINAR] EU or US approval?

What is the best starting point for innovative Medical Devices & IVD companies?


With the deployment of MDR and IVDR, there is significant pressure to update the compliance documentation of medical devices, within a short amount of time. The notified bodies are also facing increasing workload due to a large number of conformity assessments.


Meanwhile, some companies identify that some products may be easier to bring on the US market during this burdensome EU phase.


This webinar covers both sides of this situation:

· What can be done to get existing devices approved under the new EU regulations
· How does the FDA pre-submission meetings help in the approval process?
· What is the best starting point for innovative companies: EU or US approval?


In this on-demand webinar, our experts Philippe Etter and Dr Milind Raje will guide you through the changing trends in EU and FDA approvals for medical devices and IVDs:

· MDR current status (including IVDR touch)
· The latest guidance from Notified Bodies
· Dealing with Notified Bodies
· Why are innovative companies trending towards US?
· Status of availability of FDA
· General Regulatory trends


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