NAMSA Webinar: EU vs. US – Which Market Fits Your Device Strategy?
Choosing the right market for an initial launch can be challenging for medical device innovators. While regulatory requirements often play a central role in early decision-making, successful market entry depends on a broader range of factors, including clinical evidence, reimbursement pathways, commercial opportunities, and adoption dynamics.
This webinar, hosted by NAMSA, a member of the network, provides an overview of the key considerations influencing market entry and commercialization strategies in the U.S. and Europe. It explores how regulatory, clinical, reimbursement, and commercial factors can be assessed to identify the market strategy that best aligns with a medical device’s characteristics and business objectives.
Key Learning Objectives:
- Regulatory: Understand key differences between FDA and EU MDR requirements and timelines.
- Commercial: Explore market opportunities and factors influencing adoption.
- Clinical: Compare evidence expectations across the U.S. and Europe.
- Reimbursement: Gain insight into market access and payment pathways.