Certifications

Certifications

You’ll find all our certificates below.
Click on the button to download it in pdf format.

ISO 13485 certificate


 

Our three sites are ISO 13485 certified by Bureau Veritas.

 

ISO 13485 is the standard that defines quality management system requirements for medical device manufacturers.

 

This standard helps us implement procedures to guarantee the safety and quality of our products, from design to after-sales service.

IS0 13485 certificate (pdf)

 

CE certification


 

All our products are CE marked, meeting the general requirements of Regulation (EU) 2017/745.

You can download the CE certificate for your product from the “Documents” tab on the product page.