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).
M0 : Introduction to the world of devices
Description of the Medtech ecosystem
Description of the product life cycle
Positioning and interaction of the stakeholders involved
M1 : 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
M2 : Quality Management
Structuring the Quality Management System
Organizing the documentation and its evolution
Supervising process control
Managing quality processes ; audit, improvement, changes
M3 : Clinical Affairs
Structuring and organizing clinical / performance evaluation
Organizing a clinical investigation
Conducting a literature review
Managing surveillance and post-marketing study