Specialty – Medical Device and Regulatory Affairs (DMAR)
The UTC Master’s degree- DMAR has been devised according to the new European regulations on medical devices (MDs) and concerns a new and regulated profession – head of ‘compliance, quality and standardisation’ for MD designers, manufacturers or operators. This UTC Master’s degree programme address the key issues that relate to the patients’ safety and the training will provide actors who will be in a position to integrate the importance of biomedical technologies whilst ensuring application of new provisions of an evolving international regulatory scene.
UTC – and especially noteworthy its Department of Bio-engineering – was and still is a pioneer and ranks among the leaders in France in terms of biomedical work and quality assessment (QA). The UTC Master's degree – DMAR relies on the pluridisciplinarity of its teaching teams to provide knowledge and know-that relate to processes that ensure safety and regulatory compliance of medical devices (MD).
Project-oriented workshops and case studies allow the students to develop aptitudes and skills needed for health-related regulatory professions.
A considerable fraction of course time is given over to guest lectures, delivered by both health sector and industrial specialists.
To be in a position to:
- master European and international regulations for Medical Devices (MD);
- guarantee quality and safety of medical devices in full compliance with regulation throughout the life cycle of the MDs;
- ensure the interface between the various biomedical company units to guarantee satisfactory compliance of all its products and processes;
- master internal and external audit/inspection operations.