Meetup #19 - EU or USA, what's a startup to do?

As the EU is increasingly regulation heavy, some startups are considering launching their product in the USA first. With limited budget you can unfortunately only pick one. In this session we'll discuss the pros and cons of going into the USA with the FDA vs the EU with the MDR.

The US seems very tempting with a more unified market, more innovative regulations and a clearer timeline for getting approved. But: is it true, and is it feasible for an EU company to breach the US market?

Main speaker
We are joined today by Judith de Wilde of Axon Lawyers. The excellent Amsterdam based firm that has built a reputation as a regulatory thought leader.

Panelists
Amit Relia - VP of Quality and Regulatory Compliance at iRhythm - For the US perspective
Leon Doorn - Independent Medical Device Quality, Regulatory and Information Security consultant - for the EU perspective

Agenda
5 minutes - General Intro
20 minutes - EU vs US trade-offs - Judith de Wilde
30 minutes - Panel discussion - including audience questions

Recordings
Please be aware that we are recording this meetup to share the knowledge afterwards. Anyone in the recording will be asked to approve the videos before we post them. Previously recorded editions are here:
- #16 - Internal & External Audits - https://www.youtube.com/watch?v=W8BIgkrHQUk
- #15 - SOUP - https://www.youtube.com/watch?v=kVabI-fy5Rk
- #14 - Usability Engineering - https://www.youtube.com/watch?v=VprGkFDaoaU
- #13 - How to Start (over) - https://www.youtube.com/watch?v=1Dv0F2V-Xf4
- #11 - Post-Market Surveillance - https://www.youtube.com/watch?v=KsncXoicVbg