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Market access to US for medical devices

Are you a startup developing a medical device or in-vitro diagnostics product? Are you wondering if market access via the FDA is easier compared to CE certification in Europe? Then this event is for you. We will explain the product classes in the US, show you the different approaches of conformity assessment and share insights about costs and timing. At the end of this workshop, you will understand how to identify your route to the US market and know how to collaborate with the FDA.

Program

15:30

Door opening

16:00

Welcome
Basel Area Business & Innovation & Effectum Medical AG

16:05

Market access to US for medical devices
Nila-Pia Rähle, Effectum Medical AG

18:00

Networking Apéro

Participation is free, however registration is required before August 29th 2023.

For further information

For further information regarding the event registration process, please do not hesitate to contact
Mariana Rado
Manager Digital Events
Tel.: +41 61 295 50 00
E-Mail: events@baselarea.swiss