Quality assurance

Certified for quality and safety

We devote our attention to the quality and safety of our processes and the products we offer. To guarantee a constant care for quality assurance, we operate a Quality Management System which complies with the requirements of:

• EN ISO 13485:2016
• ISO 9001:2015

In addition, we support our distributors in terms of quality and safety in every possible way.

All our medical devices are produced under the current regulatory structure of the Medical Device Regulation (EU) 2017/745.

More information about quality assurance
Please email us for more information about our quality assurance.