'Safety Tested' - Primara
UFSK-OSYS products are certified by Primara Test- und Zertifizier-GmbH in accordance with the standard IEC 60601-1 Medical Electrical Equipment Safety.
"Made in Germany" all over the world
Using state-of-the-art manufacturing technologies, our highly qualified staff is dedicated to constantly optimizing the excellence of all products made by UFSK-OSYS and bearing the prized and coveted "Made in Germany" seal of quality. The numerous other certifications bestowed on us reflect our ambition to never lose sight of our customers' satisfaction on all levels - from manufacture to advisory services all the way to outstanding customer support.
Certifications confirm UFSK-OSYS quality
Certifications in accordance to ISO 9001:2008 and DIN EN ISO 13485:2012 underscore the high priority of quality assurance and quality optimization upheld by our organization. Our commitment to quality in the areas of customer satisfaction and service, as well as our dedication to meeting and exceeding the highest manufacturing standards, is yet again confirmed with these certifications. Please contact us to request the latest copies of our certifications.
ISO 9001:2008 certifies - on the basis of a comprehensive quality management system - an organizations ability to consistently produce high quality products that meet all legal, regulatory and customer requirements.
DIN EN ISO 13485:2012 conform - in the specific field of medical engineering - an organizations quality management system and the ability to consistently provide medical devices and related services that meet all legal, regulatory and customer requirements.
UFSK-International OSYS GmbH has been certified as “Known Consignor” on 4 March 2013 pursuant to chapter 188.8.131.52 of Commission Regulation (EU) 185/2010.
We have our air cargo considered “secure” after this date, exempting it from standard security screening procedures before being loaded onto the aircraft. Benefits for our partners:
- Fast and efficient handling of air freight shipments
- No additional costs due to additional storage, X-ray, delivery delays
- Air Freight may be shipped in passenger aircraft (more frequent flight possibilities
"FDA registered" for the U.S. American market
Our products have been approved for the U.S. American market by the FDA Premarket Notification 510(k) for medical devices. We are in compliance with the stringent requirements demanded by the U.S. Food and Drug Administration (FDA) for the quality management system used in production, process controlling, corrective and preventive actions, product development, and management.