EN ISO 13485 is the European Union's quality assurance standard for medical devices.
The quality management is permanently checked, audited and certified by DEKRA.

 

Download EN ISO 13485:2016 + AC:2018 + A11:2021

Download EC Certificate Nr. 50759-17-04 for the Quality Assurance System

Download Annex to the EC Certifikate Nr. 50759-17-04

 



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