Mariano Chiusano is a Chemical Engineer with more than 20 years of experience in the medical device sector covering different roles in Quality and Regulatory Affairs within Johnson & Johnson for different medical devices classes in Endo-surgery, Cardiology, Orthopedics.
He has been spending the last 7 years in Diabetology expanding his experience to In vitro Medical Devices and Digital products covering the role of Legal Manufacturer for the systems for the measurement of blood glucose and insulin delivery.
EUDAMED, the European Medical Device Database of Medical Devices is one of the most significant changes introduced by the new European Medical Device Regulations on Medical Devices (MDR) and In Vitro Diagnostics Medical Devices (IVDR). As the core of the new regulatory system of MDR and IVDR, a lot of resources and efforts have already been spent by the EU Commission and different stakeholders to design, build, validate and further develop the database. This presentation will analyze the current status of EUDAMED and future improvements of one of the most challenging European Initiatives ever introduced in the medical device sector.View Details