Medical devices: from design to market (DMCC)

The objectives of the course are to provide students with knowledge and skills on all stages of the medical device life cycle (from design to marketing)

To train managers specializing in the design, evaluation, production and regulation of medical devices, by developing students' ability to adapt to the scientific, industrial and societal environment through a sandwich course and interactive learning methods.

Ability to design a medical device from scientific and technical bases on biomaterials,

 Master the specialties of the medical device throughout its life cycle in the company (R&D, Production, Regulations, Quality, Marketing...).

• To design projects in compliance with international regulations, to put in place the conditions and controls to ensure quality, from design to marketing of medical devices;
• Establish and maintain all documentation inspectable by the International Health Authorities.
• Analyze the existing situation and determine the parameters of evolution leading to innovation.
• To study and determine the procedures to be followed for each manufacture - To constitute the files of CE marking
• Master and understand the different stages of design of a medical device. Establish the specifications of an application. To constitute a design file. To situate health products and their design in their regulatory framework.
• Analyze the scientific, medical and economic interest of a new medical device according to the state of the art (scientific article, patent, methods of valorization...), according to production costs and yields).