SoftBlue Spółka Akcyjna

-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; -the reporting obligations are fulfilled; -in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV MDR is issued