Objectives

IUFC

At the end of this certificate, students will be able to :

  • Master the consequences of the regulatory changes due to the MDR 2017/745 and the IVDR 2017/746 directives, related to medical devices and in-vitro diagnosis

  • Display strategic, tactical and communications skills when interacting with Notified Bodies and Authorities, in particular when facing crisis situations

  • Display managerial capabilities surrounding production and marketing processes for new medical products

  • Develop technical expertise in key topics such as risk management, biocompatibility, usability, clinical investigation and evaluation, and software validation

  • Provide management and engineering support during the development projects for new biomedical products