Orto step d.o.o.

check the conformity of devices in accordance with the quality management system (QMS) the company uses before the device is released, ensure that technical documentation and the EU documentation of conformity are generated and up-to-date. make sure the company complies with post-market surveillance obligations, responsible for ensuring that the company fulfills its reporting obligations, ensure that the statement from Section 4.1 of Chapter II of Annex XV of the MDR is issued