In the new MDR and IVDR regulations, all manufacturers should have a quality management system in place to ensure that mass-produced products comply with the legal requirements, which should be proportionate to the risk class and type of product concerned. The Quality Management System should be established, documented, implemented, maintained, constantly updated and systematically improved. The system should cover all parts and elements of the manufacturer's organisation dealing with the quality of processes, procedures and products, and manage the structure, responsibilities, procedures, processes and resources within the company.