Officers and regulatory representatives of StrabiScan Sp. z o.o.
DOMARADZKA Aleksandra
- 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 TD and the EU DoC are drawn up and kept up-to-date;
- the PMS obligations are complied with in accordance with Article 10(10);
- the 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