• Responsible for compliance of QMS with the EU MDR 2017/745, ISO 13485 standards, and other regulatory requirements.
•the conformity of the devices is appropriately checked, in accordance with QMS 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;
• PMS obligations, The reporting obligations; internal audit.
• preparation and attendance of external audit program