The US is the world’s largest medical device market, accounting for nearly 40% of global spend, but entering it successfully takes more than regulatory compliance. Join our exclusive webinar and learn from leading experts, including a former FDA official, how to accelerate market access and unlock growth opportunities.
The US market offers unmatched growth potential — but only for companies that get the regulatory strategy right. This session brings together a former FDA insider and leading regulatory and patent experts to share firsthand knowledge of what the FDA expects, what’s changing in 2026, and how to avoid the missteps that delay market entry.
Why this matters to you
- How to select the most effective FDA pathway for your device
- Key pre-market requirements for international manufacturers
- The Quality Management System Regulation (QMSR) 2026 and what it means for your business
- Common FDA expectations and how to avoid costly mistakes

Former FDA Lead Engineering Reviewer

Regulatory Business Development Director ClarkeModet España