Madeleine Hoffmann, MSc

Madeleine has over 14 years of experience in quality management and regulatory affairs for medical devices. During her nine years in the Notified Body and certification environment, she gained deep expertise in conformity assessment and the interpretation of regulatory requirements and standards. As a member of the OVE standards committee, she contributes to the development of future ISO and IEC standards for medical devices. She holds a Master's degree in Biotechnological Quality Management and a Bachelor's degree in Molecular Biotechnology.

At Valeriot, Madeleine leads the regulatory pathway to market access in both the EU and the United States. She ensures alignment with applicable standards and regulations, and oversees the company's quality management system to support the development of safe and effective medical devices.