MITOS Receives EU Quality Management System Certificate Under MDR 2017/745

We are proud to announce that MITOS has been awarded the EU Quality Management System Certificate, issued by UDEM A.Ş. under Annex IX, Chapters I and III of (EU) 2017/745 Medical Device Regulation (MDR).

This certification, numbered MDR.2292-2026/0046, confirms that MITOS has established, documented, and implemented a quality management system that meets the regulatory requirements set out by the MDR for our S.A.F.E. (Scan and Find Early) Microwave Breast Cancer Screening and Diagnosis System, a Class IIa medical device.

Achieving this certification is the result of a rigorous conformity assessment carried out by UDEM A.Ş., an EU Notified Body (No. 2292), covering our processes for design, development, production, and post-market surveillance. It is subject to periodic surveillance assessments to ensure our quality management system continues to meet the highest regulatory standards.

This milestone marks significant progress on our path toward full CE certification for S.A.F.E. under the EU Medical Device Regulation, reinforcing our commitment to delivering safe, effective, and high-quality medical technology for breast cancer screening and diagnosis.

The certificate is valid until 23 July 2031. You can download the full certificate (PDF) for reference.

At MITOS, we remain dedicated to advancing early detection and screening of breast cancer through innovative, reliable, and rigorously certified medical technologies.