Phytopharm Klęka S.A.

ensuring that post-market surveillance obligations are complied with in accordance with Article 10(10) of Regulation and that reporting obligations referred to in Articles 87 to 91 are fulfilled and in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued

management of the quality management system

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

ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date