Our quality management


Quality has characterized our processes since the very beginning. As an international export company, UFSK-International OSYS pays attention to worldwide quality standards.

Weltweite Zertifizierungen von UFSK-OSYS

Continuous improvement

Certified quality at the highest level

As a German manufacturer of medical devices, we develop products that are used in hundreds of workplaces worldwide. We are aware of our great responsibility – that is why the quality of our OR equipment and the safety of our customers and their patients are our top priorities. As part of our quality management, we strive to continuously improve our processes and strictly adhere to globally recognized standards.

kiwa tested IEC/EN 60601-1

Tested safety for medical application


Our medical devices are extensively tested by recognized, independent test houses. Here, the focus is particularly on the requirements for the special performance and safety features for use on patients and their use by qualified personnel in medical rooms.
The constant control of standards and the fulfillment of the special conformity requirements applicable to us are our ultimate quality goal and thus ensure the continuous safety for patients and users alike.

Worldwide seal of quality

„Made in Germany“

Our highly qualified employees use the latest manufacturing techniques to ensure constantly optimized quality and give all UFSK-OSYS products the valuable “Made in Germany” seal of quality.

ISO 13485 International Organization for Standardization

Quality in all areas:


We define “quality” not only by the end product but in all processes, and we are dedicated to continuous improvement. We believe in supreme quality – both in our products and in our services – and we dare you to put us to the test! Our certified QM system meets the requirements of ISO 13485:2016, i.e. it meets the particular performance and safety criteria imposed for the development, manufacture and sale of medical devices.
Beyond complying with the technical product standards (DIN/EN/IEC) and legal conformity requirements (CE, FDA, etc.), we are living these quality standards. Both “before” and “after” a customer’s purchase, UFSK-OSYS’s staff makes sure of giving the best possible support: best-possible choice of products, regulatory support, shipping, and after-sales service.

„FDA registered”

for the US market

Our products are approved for the U.S. market. We meet the high requirements of the U.S. Food and Drug Administration (FDA) in terms of quality management system for production, process controls, corrective and preventive actions, product development and management.