It has become the very first driving simulator to be awarded this mark, which guarantees the quality and safety of medical devices. This opens up new opportunities for Develter Innovation to market the Rehab Evolution to rehabilitation and healthcare centres and to continue its international roll-out.
The CE Medical Device marking: a strict European requirement
The CE Medical marking is governed by European Regulation (EU) 2017/745: it certifies that a medical device meets the most stringent requirements in terms of safety, performance and effectiveness.
This approach is based on a rigorous process comprising the implementation of a quality management system, the preparation of comprehensive technical documentation, risk management and the organisation of the device’s traceability.
In this context, electrical safety and electromagnetic compatibility tests in accordance with the IEC 60601-1 and IEC 60601-1-2 standards were carried out by EMITECH, helping to demonstrate the device’s compliance with the applicable regulatory requirements.
Following this demanding process, the Rehab Evolution is the first driving simulator to have been developed in accordance with Regulation (EU) 2017/745 on medical devices.
What this means for Develter Innovation
For Develter Innovation, the declaration of conformity of the Rehab Evolution with the European Medical Devices Regulation (MDR) marks the starting point for its international expansion. Many markets and institutional tenders require this certification in order to list equipment. The Rehab Evolution is currently the only product in the driving simulator category that meets this requirement.
A structural competitive advantage, which builds on more than ten years of partnership with MEDIMEX and collaboration with healthcare professionals.