Independently reviewed quality

This is where you will find the inspection certificates that vouch for the quality of DIR® medical devices. In addition to this, we maintain an internal quality assurance system that is oriented on EN ISO and provide our customers with optimal guarantees for all DIR® medical devices with the DIR® Partner Card. Don’t just take our word for it!

ZEN ISO 13485 certificate: 2012

EC Declaration of Conformity (product quality assurance) pursuant to Annex VI of Medical Devices Directive 93/42/EEC, certificate no.: 572913