Regulatory framework for medtech and digital health companies

Regulatory approvals and processes in medtech and digital health sectors

Last December in the U.S. Embassy in Paris, the Hauts-de-France region and the State of Maryland signed a memorandum of understanding to develop economic and trade opportunities. To foster this relationship, Eurasanté and the State of Maryland have decided to offer a series of webinars to highlight the opportunities for healthcare companies to enter the European and American markets

This third webinar will help you navigate the regulatory systems by giving you information on the approval processes with an emphasis on clinical requirements. It will give you some insight on how to obtain the CE marking or the FDA approval for your drug, medical device, or e-health app.

This webinar will help you:

• Get an overview of regulatory prerequisites in this sector
• Discover the clinical requirements to get the CE marking or FDA approval
• Meet experts who will share their experience on approvals and processes

Speakers :

• Joshua D. Levin, Ph.D, Director, Quality Assurance and Regulatory Affairs, Asell
• Daniel Decruppe, Expert MD101

By registering, you agree to receive emails from the organizers about this webinar cycle (connection reminders, access to the replay of the webinars)