US Market-Entry Masterclass - FDA Regulatory Roadmap is an online masterclass aimed at medical device and life science product companies seeking to expand into the U.S. market. This 90-minute session, organised by GTM Global in association with QRx Partners, will provide crucial guidance on navigating the complex U.S. regulatory landscape, especially FDA requirements.

Key topics include FDA quality management fundamentals, differences between UK/European and U.S. regulatory systems, and strategies for securing product approval and clearance. Participants will also learn about risk-based approaches to regulatory strategy, quality management, and best practices for communicating with the FDA.

The masterclass, led by Mark Swanson, a regulatory expert with over 25 years of experience, is designed for UK and European business owners, product developers, and regulatory teams aiming to enter the U.S. market.