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News from
UFSK-OSYS

ISO-upgrade

UFSK-International OSYS GmbH is ISO 13485:2016 certified!

The internationally most recognized standard for documented quality in the medical engineering industry is a company's and its quality policy's rating by the ISO 13485* standard.

Since effect from 2017, this systematic review of all UFSK-OSYS business processes will be performed by an independent auditor from the accredited certification body QS Zürich AG.

From March 2019 revised standards of ISO 13485:2016 must be met. Even greater and more intensely risk considerations must be implemented in all quality processes  and regulatory requirements need to be included as well!

Our new ISO 13485:2016 certificate confirms:

UFSK-International OSYS GmbH also meets these increased, new requirements.

This positive result reaffirms our quality policy and is a powerful motivator for us to continue developing and building optimized treatment tables, surgeon‘chairs and assistant‘sconfir stools for special treatment techniques in an ongoing dialog with our suppliers & customers.

Distribution to new markets will be regulation-compliant thanks to the ISO 13485 certification awarded to our company. We will gladly support interested distributors in becoming potential UFSK-OSYS representatives and developing the registration of our products in new target countries. Already existing registrations are kept upto date by the upgrade certificate.

Click here to download our new certificate:

Download Certificate (pdf)

Please do not hesitate to contact us about any questions, suggestions or requests you may have!

 

We are looking forward to hearing from you!

The UFSK-OSYS Team

 

* ISO 13485 standard: "Medical devices: Quality Management Systems – Requirements for Regulatory Purposes“