‘AI as a Medical Device’. An advanced course for understanding the regulatory, technical, and clinical challenges of artificial intelligence applied to medical devices
The course, organized by the Sant'Anna School of Advanced Studies in Pisa, provides an up-to-date overview of the innovations and challenges that emerging technologies such as AI pose for the design, manufacture, and marketing of medical devices. Registration is open until Friday, February 27, 2026.
Registration is now open for the advanced training course ‘AI as a Medical Device’, a three-day intensive course dedicated to analyzing the main innovations and critical issues that artificial intelligence poses in the design, production, and marketing of medical devices. The course is organized by the Dirpolis Institute of the Sant'Anna School of Advanced Studies in Pisa, under the scientific guidance of Andrea Parziale and Francesca Gennari. Registration is open until Friday, February 27, 2026.
"Artificial intelligence is profoundly redefining the medical device industry, affecting the processes of design, validation, and market entry. In this scenario, it is increasingly necessary to train professionals who are able to understand not only the innovative potential of these technologies, but also the constantly evolving regulatory framework and the responsibilities that come with it, in order to ensure safety, compliance, and clinical quality," comment the two course leaders, Andrea Parziale and Francesca Gennari.
Course objectives
The course, delivered in English, offers an up-to-date overview of the European regulatory framework, with particular reference to the European Medical Device Regulation (MDR) and the Artificial Intelligence Act (AI Act). The course focuses on risk analysis and the integration of regulatory requirements, approached from a multidisciplinary perspective that combines legal-regulatory, technical, and clinical expertise.
Who it is aimed at
AI as a Medical Device is aimed primarily (but not exclusively) at professionals in the medical device sector, but also at consultants, corporate lawyers, lawyers specializing in health law, researchers, AI developers for medical and e-health applications, healthcare professionals, and private companies of all sizes (start-ups, spin-offs, SMEs, multinationals). The adoption of the MDR and the entry into force of the AI Act have significantly increased the complexity of compliance obligations for manufacturers. In particular, artificial intelligence systems classified as medical devices (or part of them) are subject to a dual regulatory regime, which requires specific expertise to be applied efficiently. The course aims to provide analytical and methodological tools to address these regulatory and operational uncertainties, also taking into account the economic and clinical implications that characterize daily practice.
The teaching program
The course is structured in three modules: AI and medical devices: clinical practice and regulatory challenges; AI and medical devices: technical perspectives; AI and medical devices: product liability.
All information about the course can be found at the following link: https://www.santannapisa.it/it/alta-formazione/Artificial-Intelligence-as-medical-device
