Keynote lecture: Smart regulatory strategies for cost-effective market entry

Maria Duguine Carrasco, an international regulatory affairs expert with over 20 years of experience, will explore actionable strategies to enter global medical device and IVD markets efficiently and affordably.

Drawing from hands-on experience navigating EU MDR/IVDR, UK, US, and other key jurisdictions, she will highlight pathways that minimize regulatory burdens without compromising compliance. The session will cover low-cost routes, leveraging special access schemes, smart geographic targeting, and practical tips for startups and SMEs aiming for fast, sustainable market entry.