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 Affairs
-
Structuring and organizing clinical / performance evaluation
-
Organizing a clinical investigation
-
Conducting a literature review
-
Managing surveillance and post-marketing study