21
June
Regulation

We are pleased to inform you that we have passed the annual inspection which included the renewal of the ISO 13485: 2016 and ISO 9001: 2015 certificates, as well as the evaluation of the new technical files for class I devices certified according to MDR. This renewal confirms our main objective of maintaining high quality standards and guaranteeing patient safety: all class I devices of our production comply with the new regulation on medical devices MDR 745/2017. The next goal, within the expiry of the certificate, remains that of making devices of classes above I compliant with the regulation.


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