Przedsiębiorstwo Wielobranżowe Biomex Sp. z o.o.

Responsible for ensuring that: -the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -the post-market surveillance obligations are complied with in accordance with Article 10(9) of IVDR