1. Ensure conformity of the device is appropriately checked according to the QMS before release; 2. Ensure STED and EU DoC are drawn up and kept up to date; 3. Ensure PMS obligations are met; 4. Ensure reporting obligations relating to vigilance are met; 5. Ensure that the declaration for investigational device(s) used in clinical trials conforms to GSPR apart from aspects covered by the clinical investigation and every precaution has been taken to protect the H and S of the subject.