Miriana Jlenia QuattromaniSenior Scientific Manager at 3ShapeSpeaker
Profile
Miriana Quattromani is a scientific and regulatory expert with over eight years of experience in the medical device industry. Currently serving as Senior Scientific Manager at 3Shape, she leads clinical evidence generation and regulatory strategy across global markets, including the EU, USA, Japan, and South Korea. Her expertise spans MDR compliance, Al act, FDA submissions, clinical investigations, post-market clinical follow-up, post-market surveillance, and vigilance activities. Miriana holds a PhD in Biomedicine. She has authored multiple peer-reviewed publications and brings a strong background in experimental design, data analysis, and international project management. With a passion for bridging science and innovation, Miriana plays a pivotal role in enabling software and hardware product development and regulatory approvals in the medical device industry.
Agenda Sessions
Case Study Conversation: Clinical evidence for Al/ML devices & diagnostics: Navigating regulatory challenges under the MDR and FDA frameworks
, 15:30View Session
