Marketing a digital medical device - KATI9M27

Goal(s)

The aim is to present medical devices (industrial sectors, definitions and types of medical devices), as well as the regulatory framework (actors, notified agencies and standardization processes)
The module is organized around e-learning and presentations by industry experts. It is put into practice through a project with case studies.

Content(s)

1/ Introduction
Regulatory context and DM marketing
Concept of DM and DMN

2/ DM life cycles
Introduction to the life cycle
Economic operators
Notified bodies
Essential requirements
Harmonized standards
Clinical investigation
Technical file
Audit
Product recall
Market surveillance

3/ Project-based case studies