REGIONALNE CENTRUM ZDROWIA SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Ensuring that: the conformity of the devices is appropriately checked, in accordance with the QMS 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 Article 10(10); the reporting obligations referred to in Articles 87 to 91 are fulfilled; the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.