The curriculum is organized in four modules designed to cover in depth the different aspects of the training themes in a logical and progressive way. A personal report will have to be written by the participants, providing a personalized backbone through the entire training.

All the material related to lectures and training is available via the Moodle webpage of the certificate (accessible only to registered students).

M1 : Introduction to the world of devices

  • Description of the Medtech ecosystem

  • Description of the product life cycle

  • Positioning and interaction of the stakeholders involved

M2 : Regulatory Affairs, Design and Submission

  • Structuring and managing risks

  • Merging regulatory requirements with a design

  • Managing the implementation of guidelines, standards and recommendations

  • Managing software compliance

  • Supporting product design and industrialization

  • Structuring document ation of regulatory submissions

  • Managing market events, incidents, announcements, reminders

  • Maintaining regulatory compliance over time

  • Preparing the company for audits

M3 : Quality Management

  • Structuring the Quality Management System

  • Organizing the documentation and its evolution

  • Supervising process control

  • Managing quality processes ; audit, improvement, changes

M4 : Clinical

  • Structuring and organizing clinical / performance evaluation

  • Organizing a clinical investigation

  • Conducting a literature review

  • Managing surveillance and post-marketing study