In the context of the activities for promoting the UBORA platform and importance of harmonization of medical device regulation, an UBORA workshop was held at University of Bologna, the oldest University in Europe, on February 26th.
The workshop, hosted in the course Biomedical Engineering for Developing Countries, thanks to the invitation of professor Stefano Severi, was organized in two sessions. In the morning we presented the UBORA design methodology, starting from clinical needs and putting emphasis on standards and regulation. The importance of harmonization of medical device legislation, in the context of global and local healthcare challenges, was one of the themes of discussion. In the afternoon, after an overview of the European Medical Device Regulation 2017/745, the students had the opportunity to do guided exercises on the classification of Medical Devices using the tools provided by the UBORA platform.