Certifications

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
UFSK-OSYS Prozess-Flowchart

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

Kiwa

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.

High Quality Made in Germany

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

Quality in all areas:

ISO-13485

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 certifi ed 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, UFSKOSYS’s staff makes sure of giving the best possible support: best- possible choice of products, regulatory support, shipping, and after-sales service.

Known Consignor

“Known consignor”

in the air freight sector

UFSK-International OSYS GmbH has been recognized as a “Known consignor” by the German Federal Aviation Office since 04.03.2013. “Known consignor” is the status that entitles to send so-called “safe” air cargo. The “Known consignor” is part of the security initiative of the EC (VO(EG) Nr.300/2008) in the fight against international terrorism. These are companies (manufacturers, traders) that regularly send goods by air freight and have been classified as reliable and trustworthy.

 

  • Advantages for the consumer:
    • Fast and efficient processing of shipment by air freight.
    • No extra costs due to additional storage, X-ray, delivery delays
    • Air freight may be shipped in passenger planes (much more options for shipping)
FDA registered

„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.