2017/745 MDR compliance

MDR compliance: A guarantee of excellence in the quality and safety of our medical devices

Stephanix is delighted to announce the MDR 2017/745 certification for its D²RS x-ray remote-controlled systems, marking a significant step forward in its commitment to the quality, safety, and performance of its products.

What is MDR (Medical Device Regulation)?

The MDR 2017/745 is a regulation that governs the European medical devices market.

This regulation aims to ensure the safety, efficiency, and performance of our solutions throughout their entire life cycle.
After evaluation, ta notified body delivers the CE marking to certify the conformity of medical devices.

A certification that promotes excellence in the medical imaging field.

Obtaining MDR certification marks a major milestone for Stephanix and confirms our position as an international leader in the remote-controlled rooms market.

This certification reinforces our commitment to the highest standards of quality and safety, while opening up significant new growth opportunities across the entire radiology market.