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