Quality assurance

Certified quality and safety

We devote a lot of attention to the quality and safety of our processes and products. To safeguard safety and quality, we operate a quality management system which complies with the requirements of:

• EN ISO 13485:2016
• ISO 9001:2015

In addition, we support our distributors with respect to quality and safety. We do this by providing documents, setting up protocols and guaranteeing a proper use of products.

Obviously, all our medical devices comply with the Medical Device Directive 93/42 ECC. See our EC Certificate on Medical Devices, Annex II excluding Section 4.