The WOmed T-105 has successfully obtained certification under the European Medical Device Regulation (MDR). This confirms that the system meets the current European requirements for safety, performance and clinical evaluation of medical devices.

The WOmed T-105 had already been MDD certified for many years and is well established in clinical practice internationally. This long-standing market presence and clinical experience provided a strong foundation for the transition to the MDR framework.

As part of the MDR conformity assessment, key elements such as the technical documentation, risk management, clinical evaluation and post-market surveillance processes were thoroughly reviewed and approved. The MDR certification highlights the regulatory maturity and long-term viability of the WOmed T-105.

A recently released video provides insight into the clinical use of the WOmed T-105 in Australia, illustrating its application in everyday clinical settings outside Europe.

Watch the video here:

https://youtu.be/Uj6XoKbeudw?si=Xf7KknA-09JxES0z