Medical Doctor (Université Louis Pasteur, France) with 25 years in medical device development. I joined PVT at its creation and took part in developing the first percutaneous heart valve (PVT is now part of Edwards Lifesciences), which led to publications. Since then I have served as Medical Director for several companies, led successful clinical trials and regulatory submissions worldwide, and acted as Medical Reviewer for European Notified Bodies. Experienced in board-level strategy, M&A due diligence and audits, and start-up advisory boards across Israel, the US and France.

n 2020 I founded MedTech SME Advisors, an international network of MDs and PhDs who are subject matter experts in clinical and regulatory affairs. We partner with start-ups and established manufacturers on EU MDR/IVDR CE marking and FDA 510(k), De Novo and PMA, increasingly for AI-based and software devices. Today my focus is where innovation meets evidence: clinical data strategies regulators accept, AI applied to regulatory work without cutting corners, and keeping devices on the market after audits. Innovation only matters once it reaches patients.