WE WARRANT TRANSPARENCY

QUALITY MANAGEMENT AND DOCUMENTATION

  • documentation of all process steps
  • DQ, IQ, OQ, PQ
  • product accreditation audit
  • suitable machines and plants
  • FDA registration: owner/operator No.: 10043226
  • accredited as foreign medical device manufacturer in Japan

Quality determines our approach throughout all processes. In all work steps, our employees implement our quality management in compliance with EN ISO 9001 and EN ISO 13485.

We record all process steps according to the parameters defined in the validation documents. As basis for the product accreditation, we provide our customers with an extensive documentation and explain this, if desired, in the scope of product accreditation audits.



 

 

 

INQUIRY