The EU MDR regulations are intended to improve the safety and performance of medical devices in Europe. As a manufacturer of medical devices, NordicNeruoLab welcomes the updated requirements and fulfilling the new regulations has been a top priority for us.
On May 26th 2021, when the EU Medical Device Regulation came into effect, NordicNeuroLab fulfilled the new requirements.*
The work towards becoming compliant with the new regulations has been resource-demanding and extensive as it involved changes to our quality management system and business processes.
Thanks to our VP Quality, Chandana, for leading this important work.
*not applicable for nordicBrainEx.