Medsource Ozone Biomedicals Private Limited

a) Supervision and control of the manufacture of devices in accordance with the quality management system (ISO 13485:2016). b) The technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date. c) Post-market surveillance (PMS) of the devices of the manufacturer as per Regulation 2017/746 (IVDR), Chapter VII, Section 1. d) Vigilance activities concerning the devices of the manufacturer as per Regulation 2017/746 (IVDR), Chapter VII, Section 2.