Certifications

Our two sites are certified NF EN ISO 13485:2012.

ISO 13485 certification promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.

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

Download IS0 13485 Certificate

All our products are CE marked, fulfilling the essential requirements of European Directive 93/42/EC on medical devices as amended by European Directive 2007/47/EC.