Day 1 - Monday 15th JuneMonday, 15 June 2026 - CEST Time Zone

This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.

Participants will get an overview of the current regulatory landscape, including MDR simplification, digital omnibus, and their impact on market access & healthcare innovation. The session will discuss what stakeholders must do about it, and demonstrate relevant case studies of SME successes and failures.

Understanding how to secure appropriate clinical evidence is essential for achieving positive regulatory outcomes, whether you are bringing a new device on the market or navigating a legacy device. This session will outline principles of clinical evidence, discuss practical considerations, and highlight the importance of cross-functional alignment. Participants will learn how to think about regulatory & clinical planning