The WINTECARE group, already holding 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 stricter European Medical Device Regulation.

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

The MDR certification confirms the safety and performance of the devices concerning their intended uses.

This milestone was achieved through an in-depth clinical evaluation conducted by an accredited and independent body, which validated the therapeutic effectiveness of the devices.