Catarina Carrao

Catarina Carrão is the founder of BioSciPons, a life sciences research organisation specialising in health technologies clinical development, evaluation and assessment, with expertise in AI/ML-enabled technologies. She co-ordinates expert teams to bridge the gap between innovation and regulatory compliance, helping developers navigate complex requirements while meeting the expectations of Notified Bodies and the FDA.

Catarina's academic background includes a Marie-Curie Fellowship at Charité Berlin, and Postdoctoral Fellowship at Yale's University Cardiovascular Research Center. She is a Fellow of the American Heart Association (FAHA) since 2013, Delegate of the European Society of Cardiology (ESC), and Professional member of the Health Technology Assessment International (HTAi) organization. She is an expert for the European Commission HaDEA on clinical investigations and Digital Health Technologies, and for the European Innovation and Technology (EIT) Council Health Cluster.

She has presented at RAPS Euroconvergence, the ESC Digital & AI Summit, and DIA Europe on AI/ML medical device regulation, post-market monitoring, and reimbursement pathways. Her recent publications include book chapters and articles on machine learning best practices, AI trustworthiness, and EU MDR/IVDR clinical evaluation.