SOMATEX®

SOMATEX® quality

Our medical devices are used daily in hospitals, university clinics and medical practices worldwide. Doctors and patients trust that our instruments work reliably and safely. We live up to this responsibility by following self-defined, strict guidelines in addition to legal requirements. For us, quality is not just a matter of fulfilling what is required by law, but what we claim for our customers and for our differentiation in the market. Patient safety is our top priority and accompanies us continuously in our daily work.

High quality well thought out

As a medical company, we have a comprehensive understanding of quality. We implement this continuously and systematically in all areas of our company, always with the same goal: to provide high-quality and advanced medical devices. We take all regulatory requirements into account.

Certified Worldwide

As a manufacturer of medical devices, we are EN ISO 13485 certified. In addition to the European CE certification, we are also certified worldwide, such as by the FDA in the US, the NMPA in China or the ANVISA in Brazil.

As a manufacturer of medical devices, ensuring patient safety and the associated compliance with product and safety standards is our top priority. With an integrated quality management, we ensure that our products meet the legal requirements and satisfy our customers.

Dr. Benjamin Klasczyk, Technical Director

Certified worldwide

Our products are approved in > 40 countries.

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