Hearing from the learnings of the regulatory approval processes of MedTech entrepreneurs or advisors, this session will highlight a few critical things to take care – early on – in your regulatory journey. What are the key steps to follow to make this journey successful? When to get experts on board and how to source the right ones? How to implement the right processes in terms of requirement management, risk assessment and clinical validation? How to manage the increased spendings induced by MDR regulation? To what extent can a good regulatory approval management be a strategic advantage for your start-up?
Moderator: Patricia Gruffaz, Director, MedUniq Center