Strengthening PressCise´s competence in preparation for EU Medical Device Regulation (MDR)
| Reference number | |
| Coordinator | PRESSCISE AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | December 2019 - March 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The goal of the project was to, with the help of external expertise, implement the reorganisation of the business in accordance with EU´s new directive for medical devices, MDR, and at the same time strengthen the internal regulatory competence at PressCise. Thanks to the consultant, the company has been able to update the technical documentation for its medical devices, and has at the same time gained knowledge on how to continue working under MDR.
Expected results and effects
With the help of an external consultant, together with the company´s quality manager, PressCise has carried out an update of the company´s technical documentation in accordance with MDR. In this way, the foundation has also been laid for the continued work with MDR. In the next step, which is also a requirement within MDR, the company needs to review and implement a quality management system, this is also intended to be done in collaboration with the same consultant.
Planned approach and implementation
The consultant´s work consisted of, together with the project group, reviewing the company´s existing documentation and performing a GAP analysis to clarify which documentation tone and processes needed to be updated in accordance with MDR. Thereafter, work began on updating the relevant documents and implementing new processes under MDR. The work was carried out in close collaboration between the consultant and the project group, which resulted in an efficient way of working with satisfactory results.