WINTECARE technologies are based on scientific research, clinical expertise, sports-specific know-how, and continuous feedback from therapists and medical professionals worldwide.

The WINTECARE Group, which already holds numerous international certifications for its devices and quality management system, is proud to announce the achievement of MDR certification, in compliance with the new and more stringent European Medical Device Regulation.

This important recognition adds to those already obtained, including ISO 13485 (for medical device quality management systems), MDD (Directive 93/42), FDA certification for the United States, KFDA for South Korea, PMDA for the Japanese market, and the Russian medical device certification.

The MDR certification confirms the safety and performance of the devices with respect to their intended uses.

This result was achieved through an in-depth clinical evaluation, verified by an accredited, independent body, which validated the therapeutic effectiveness of the devices themselves.