From a training focused on the creation of medical devices and the challenges around its design in terms of biomechanics and biocompatibilities. I pursued the construction of my knowledge at the international level by carrying out an R&D project for class III medical devices. I then developed my skills and acquired a QA/RA expertise by participating in the modification of technical files from directive format to regulation format (ISO 13485, RDM 745/2017). All this, based on a QMS and a construction of the DT oriented towards an FDA certification (21 cfr part 820). The safety and performance of the product also depends on the manufacturing stages of the DM; the control of the production stages, the choice of raw materials and the transfer of the products must be at the heart of design, innovation and regulatory update projects.