While regulatory compliance is essential for bringing MedTech products to market, it is often perceived as a burden. Let’s explore how companies developing in Europe can leverage regulatory frameworks to enhance their market competitiveness.
Where are we on the impact of MDR on the development and commercialisation of MedTech products in Europe? Can companies still work their way through regulations or are we reaching a critical point of overly stringent measures? What challenges and requirements can start-ups anticipate to adapt their development strategies accordingly? What strategies can companies employ to manage the growing waiting list of notified bodies and navigate regulatory uncertainties effectively? When is it a good idea to consider the US market for EU companies?
Moderator: Kyun Thibaut, Founder & Managing Director, COVARTIM