Stephanie Berger

Director Global PMS at Philips

Speaker

Stephanie Berger is a senior Quality and Regulatory leader with over 30 years of experience in the medical device industry, spanning Class II through active implantable devices. She brings extensive knowledge of worldwide quality and regulatory requirements and specializes in post-market surveillance, global compliance, and large-scale quality system transformations, including EU MDR implementation.More recently, Stephanie has been driving the integration of AI regulatory requirements into post-market surveillance processes, focusing on governance, risk management, and the compliant use of AI in quality systems in line with emerging frameworks such as the EU AI Act.