Marylise Robert

Marylise brings over 8 years of industry experience, specializing in regulatory strategy, compliance, and product approvals for medical devices.

With a Biomedical Engineering background, she has successfully secured CE marks for Class IIb to III devices, led MDR transitions, and guided submissions for diverse technologies in ophthalmogy, orthopedics, and biopolymers. She ensures regulatory requirements are fully met, from technical documentation to market entry, safeguarding patient safety and business continuity. Known for her rigorous approach and ability to anticipate evolving requirements, she provides the expertise and reliability that MedTech companies need to navigate regulatory challenges and sustain growth