Navigating Regulatory Pathways: Implications for Medical Device Startups

Are you ready to bring your innovative medical device to market but unsure how to navigate the complex regulatory landscape? Join us for an in-depth webinar designed to help startups chart a path to success in both U.S. and international markets.

What You'll Learn:

• Key FDA pathways like 510(k), De Novo, TAP, and SteP—how they work and when to use them.
• Strategies for complying with stringent international frameworks like EU MDR and Health Canada regulations.
• Tips for clinical trial design, regulatory submissions, and early engagement with authorities to reduce risks and accelerate approvals.
• Insights into evolving policies and programs shaping the medical device industry.

Why Attend?
This session will provide actionable guidance from industry experts, ensuring you can confidently navigate regulatory hurdles while minimizing time to market. Whether you’re just starting out or scaling up, this webinar will equip you with the tools to remain agile and compliant.