Quality ManagementQualitätsmanagement

The awareness that our products are used in medically highly sensitive areas obligates us to the very highest levels of quality. Patient safety is the number one priority. A high degree of transparency is the tool we use, documenting comprehensive quality management in every aspect of our company.

The entire process, from development, finished product to shipment and delivery to the user, is subject to a full quality management system according to DIN EN ISO 13485:2016 for manufacturers of medical devices. We comply with all requirements for design and development, production and distribution.

We are authorized to sell our products throughout the entire EU, as indicated by the CE symbol.

More and more users outside of the European Economic Zone trust in our products.

The quality assurance systems in our production facilities, as well as those of our suppliers, are fully compliant with even the highest demands. We were able to expand our many years of experience in the industry into the procurement of raw materials as well, exercising quality control form the earliest moments of the manufacturing process. We perform in-process controls and final inspections during and after production and packaging processes.

The full life-cycle of our products is being monitored.

We live and breathe quality!

Certificate: ISO 13485

Certificate: ECclassI

Certificate: ECclassII+III

Certificate: JODO

Information letter: WechselNB11062015