Officers and regulatory representatives of Tribo sp. z o.o.
BURZYŃSKI Gaweł
- the conformity of the devices is appropriately checked, in accordance with the quality management system 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,
- the reporting obligations are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.