Conformity of the devices is appropriately checked, in accordance with the quality management system
Technical documentation and the EU declaration of conformity are drawn up and kept up to date
Post-market surveillance obligations are complied with in accordance with Article 10(10),
Reporting obligations referred to in Articles 87 to 91 are fulfilled,
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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POPOVSKI Dane
Technical documentation and the EU declaration of conformity are drawn up and kept up to date