Quality Management

SOMATEX® Medical Technologies GmbH products are used around the world in hospitals, university clinics and medical practices every day for sustained improvement in the quality of life of patients.

Our goal is to provide our customers and patients with products and services of the highest quality.

To fulfill our mission, both our development and production processes as well as the company’s overall business are governed by an integrated quality management system. In cooperation with our customers and partners, we are continuously working to constantly improve our guiding principles.

As a manufacturer of medical devices, SOMATEX® Medical Technologies is EN ISO 13485 certified. Our quality management system is audited each year by MedCert Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH in Hamburg, Germany, a certified quality auditor.

EN ISO 13485

EN ISO 13485

CE-Certification Cl. I

CE-Certification Cl. IIa-IIb-III