Besides bringing to you a functional, reliable and non-invasive device, we place great emphasis on it being safe and easy to use.
Safety is our top priority, and to ensure and validate the safety performance, regulatory certification based on clinical documentation must be in line.
The design and development process takes into account the current reimbursement systems implemented in Europe. We aim to bring to market an innovative product created to ease the everyday life of diabetics all over the world, but it needs to be affordable.
Keeping focus on introducing the device within the EU will allow us to limit initial regulatory expenses, and present the device as a new option for national reimbursement programs.
Where are we now?
With six new employees joining in 2017, the past year has been exciting and hectic. We are working faster than ever, and have recently launched our Quality Management System that will be used to document all of the clinical trials. This will be necessary for CE marking the final device in the nearest future.
2018 calls for further growth of the company, starting with RSP Systems moving to larger facilities. The new facilities will enable the further hiring of competences, in order for us to finalize the industrial design.