For medical device certification processes, in particular, we support partners outside Europe in CE certification procedures, provide top-level support in MDR / IVDR (and MDD / IVD) certification processes, and undertake PRRC services and assistance under MDR / IVDR. Our main activities:
• EU representation of medical devices (for CE certification)
• EU authorized representative (for CE certification)
• Support for MDR / IVDR processes of medical devices (EUDAMED, UDI…)
• PRRC service - Medical devices
We have the following main qualifications to perform our activities:
• Bachelor’s Degree in Foreign Trade and Economics (BSc);
• qualified mechanical engineer;
• Master’s Degree in fine mechanical-optical mechanical engineer (MSc);
• weak and power current electrician;
• Master Degree in Medical Engineer (MSc);
• qualified endoscopic instrument mechanic and developer;
• Master Degree in Production Management and Logistics (MSc);
• Master Degree in Flow and Fluid Mechanics (MSc);
• water-sewer utility installer / maintenance
You can find more information about these and about our own production in further menus. Should you have any questions, please feel free to contact us.
