Specialty – Medical Device and Regulatory Affairs (DMAR)

This course is open to UTC apprenticeship candidates.

In addition to acquiring recognized scientific and technological skills, university degree apprenticeships enable students to learn professional skills that are particularly appreciated by companies.

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The DMAR program is based on the new European regulation on medical devices, and is aimed at a new regulated profession: regulatory affairs, quality and standardization manager for medical device designers, manufacturers or operators. This program is designed to meet the essential challenges of patient safety, and to train people to take on board the importance of innovation in biomedical technologies, while keeping up with changes in international regulations.

Candidater

Guide des UE

Pedagogical context

UTC-Compiegne, and more specifically its Department of Biological Engineering, is a pioneer and leader in France for training courses combining biomedical and quality aspects.

The DMAR training program draws on the multi-disciplinary skills of the teams present to provide the knowledge and know-how needed to control processes aimed at ensuring the conformity of medical devices.

Project workshops and case studies are used to develop the skills and competencies required for regulatory affairs in the healthcare sector.

Special emphasis is placed on presentations by specialists from the professional world of healthcare and industry.

Professional objectives

To be able to:

Master European and international medical device regulations.
Guarantee the quality and safety of medical devices by complying with regulations throughout their life cycle.
Interface with the various components of the biomedical company to guarantee product and process conformity.
Manage internal and external audit processes.