[WEBINAR] MDR / IVDR compliance for US companies

With the deployment of MDR and IVDR, there is significant pressure on the industry, with short timelines and a clear burden on Notified Bodies.


US medical device and IVD companies with established products have limited choice besides upgrading documentation because EU remains a dense market with 750 million inhabitants and a large hospital every other 20 miles.


For innovative companies, the question remains complex because the timelines for starting a clinical trial on complex devices remain shorter in the EU, whereas simple devices, such as Digital Health solutions, are clearly easier to develop in the USA.


This webinar covers both sides of this situation:

· What can be done to get existing devices approved under the new EU regulations
· What are tactics for innovative companies


In this on-demand webinar, our experts from our office of Philadelphia, Tamara Lewis, Paige Sutton-Smith, and Philippe Etter, will guide you through the changing trends in EU for medical devices and IVDs:

· MDR current status (including IVDR touch)
· Latest guidances from Notified Bodies
· Planning of conformity assessments for MDR / IVDR transition
· Dealing with Notified Bodies, where to go
· Clinical tactics in the EU



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