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Certification for medical devices
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Certification for medical devices
 
 
Euromex is now ISO 13485:2016 certified!
ISO 13485:2016
We are proud to announce that on top of our ISO 9001:2015 certification Euromex is now also ISO 13485:2016 certified

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system in the medical device industry

The ISO 13485:2016 certification demonstrates Euromex’s commitment to providing high quality products based on certified management processes and ensures best practices in everything we do
Beyond the ISO 13485:2016  certification our bScope and Delphi-X Observer are now certified as Class 1 devices per EU Medical Device Directive (MDR Medical Device Regulation) 2017/745

Thank you for your trust in our team
Euromex
 
 
If you have any questions please do not hesitate to contact us,
we are looking forward to hearing from you!
 
 
 
 
 
 
 
Euromex Microscopen BV, Papenkamp 20, 6836 BD Arnhem, The Netherlands
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