Events

[FREE WEBINAR for Australian-based 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?

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
· Tactics for existing portfolio of products
· Why are innovative companies trending towards US?
· Status of availability of FDA
· General Regulatory trends

Ready to join us? Register now!

If you are a Germany-based company with questions induced by the new MDR (classification, clinical testing & quality management of medical devices and in vitro diagnostics), this event is for you!

Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.

During 1 hour, our Medidee experts will answer your questions and will guide you to the next steps!

Find out more and sign up for free 👉 here

⚠️ Hurry, slots go fast! First come, first served ⚠️

Medidee – Compliance with Relevance

Thank you to our partners EIT Health Germany, Baden Campus, BioCon Valley, Biosaxony, Medical Valley & Forum MedTech Pharma