Brian Hedegaard
Topics
AI Case Examples: Market Access Experiences in EU and US
With the EU AI Act still evolving, standards rapidly updating, and limited guidance on how to interpret these rules within the broader legislative landscape, how can you ensure your product submission stands on solid ground? This session will offer practical suggestions to address these challenges. Drawing from real-world cases that bridge regulatory theory and hands-on experience, we will examine how differing regulatory pathways between the EU and the US may be leveraged and highlight effective practices for navigating Europe’s changing requirements. The session seeks to inspire strategic insights to help you mitigate uncertainty, strengthen your compliance strategy, and achieve a smoother path to market entry—even as the target continues to shift.