Quality Assurance

Uncompromised Quality, Unquestionable Authenticity

Don’t just take our word for it—when it comes to quality, we have the nod from the world’s most stringent quality management norms based on the standards of EN ISO 13485:2016 / DIN EN ISO 13485:2016 and Regulation (EU) 2017/745 on Medical Devices. These certifications have been confirmed by TÜV SÜD Product Service GmbH, Ridlerstrasse 65, 80339 Munich, Germany, a leading international certification organization.

The secret to our exacting standards lies in our Quality Control System, which incorporates a comprehensive series of microbiological, chemical, physical and visual tests at each stage of the production process. Also, every stage in the production cycle, ranging from raw material procurement to manufacturing and assembly is put through severe physical and analytical testing procedures before the final product undergoes complex qualitative testing cycles.