Project presentation

Developing a range of CUSTOMIZED TRAINING PATHWAYS for Quality, Regulatory Affairs and Clinical Affairs for the Medical Device industry

The ARCliMeD project addresses the training and skills development needs of companies in the Medical Device sector for the jobs of the future. It is fully aligned with priority 7 of the France 2030 re-industrialization plan, axis 4 of the Medical Device plan, to create the devices of tomorrow and accelerate their market access.

This is a training project whose objective at the national and European level is to increase the proportion of profiles in charge of regulatory affairs and conformity assessment in digital health.

The European regulations on medical devices (EU) 2017/745 & 2017/746 introduce the need for qualified personnel in Regulatory and Clinical Affairs to be available quickly within MD companies and stakeholders (notified bodies, health authorities, etc.).

The operating method is structured as a dynamic project in four work packages, integrating continuous improvement from its inception: it involves mapping suitable university courses, selecting teaching materials and internship and learning locations, developing innovative digital tools and integrating a "soft-skills" approach, consulting stakeholders, experts and companies in the sector, and transposing the expectations of European regulations.

The creation of a multidimensional matrix will allow for the coordination of skills needs, job profiles, career paths, and the mapping of available training programs. The alignment of educational offerings with demand will be assessed, with updates every two years.