Dirigeants et représentants réglementaires de Creator Sp. z o.o.
SKORUPKA Artur
- 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 pms obligations- complied with in accordance with Article 10(10);
- the reporting obligations (Art. 87 to 91) are fulfilled;
- in the case of investigational devices, the statement is issued (Section 4.1,Chapter II of Annex XV)