Certification – ISO 13485

As we design the future in the field of medical devices, we make our products reliable, equivalent and qualified with ISO 13485 standard, the most up-to-date and current quality management system of today for medical devices.

Our designs and offerings are CE certified in accordance with European Union standards and requirements.

Our products are designed in accordance with the directives 93/42/EEC, 2017/745/EU, 2002/95/EC, 2014/53/EU and 2014/30/EU.