On 22 September 2026 at 10:00 am to 11:00 am CET, Marco Kalms, Founder & CEO of Kalms Group, will join NAMSA’s upcoming webinar “EU vs. US: Which Market Fits Your Device Strategy?” as a guest speaker.
For medical device companies planning international expansion, deciding whether to enter the European or U.S. market first is rarely straightforward. Regulatory requirements are an important part of the decision, but clinical evidence, reimbursement pathways, commercial opportunities,, and market adoption can be equally important when defining the right strategy.
During the webinar, the speakers will compare key aspects of market entry in the European Union and the United States, including:
- FDA and EU MDR requirements and timelines
- Clinical evidence
- Reimbursement and market access pathways
- Commercial opportunities and adoption considerations
Marco will contribute his perspective based on more than 30 years of experience in the healthcare industry and his work supporting international medical device companies with market access, reimbursement and commercialization in Europe.
The webinar is organized and hosted by NAMSA, with Marco participating as an invited guest speaker alongside NAMSA experts and other industry specialists.
Marco will join David Mandley, PhD, Senior Principal Regulatory Consultant; Steven A. Farmer, MD, PhD, FACC, FASE, former Chief Strategy Officer at CMS and NAMSA KOL; and Adam Saltman, PhD, MD, Chief Medical Officer at NAMSA.
Webinar details
Date: 22 September 2026
Time: 10:00 – 11:00 am CET
Format: Online webinar
Participation: Free of charge
