Officers and regulatory representatives of IVES-System Sp. z o.o.
FLIS Mateusz
- conformity of the devices is appropriately checked;
- technical documentation and the EU Declaration of Conformity are drawn up and kept up to date;
- post-market surveillance obligations are complied with legal requirements;
- reporting obligations related to serious incidents and field safety corrective actions, including trend reporting, are performed according to legal requirements;
All in accordance also with IVES-System Quality Management System.