Additional Liability Company “TahatAksi”

Ensure that the technical documentation and the EU declaration of conformity are drawn up and kept up-to date in accordance with EU MDR. Ensure the appropriate statement is issued in accordance with EU MDR in case of investigational devices. Ensure that the conformity of devices is in accordance with the quality management system under which the device is manufactured before the device is released into the EU market.

Ensure that the post-market surveillance system obligations complied with in accordance with EU MDR