External regulatory expertise for transition to MDR

Purpose and goal: ** Denna text är maskinöversatt **

The project aimed to prepare for certification of the company MediTuner and its medical technology products under the new regulations MDR. During the project, the goal was fulfilled to, with the help of a senior consultant with expertise in MDR, support MediTuner´s QA/RA´s manager in the preparatory work and development of the quality management system and technical file, and ensured knowledge transfer to the company internally.

Expected results and effects: ** Denna text är maskinöversatt **

MediTuner has now basically completed the preparatory work for certification and is ready for an examination by the company´s notfied body. Approach and implementation: ** Denna text är maskinöversatt **

With a series of workshops in specific areas, regarding documentation and processes, for both quality management systems and technical files, ensured knowledge transfer from the external expertise to the company internally.