Sahajanand Medical Technologies Ireland Limited

To ensure conformity of devices in accordance with QMS under which the devices are manufactured. To ensure that technical documentation and the EU DOC are drawn up and kept up to date. To ensure compliance of PMS obligation per Article 10 (10) and implementation in accordance with Article 83. To Report CA/NB about reportable incidences, FSCA, trend reporting, and other obligations referred to in 2017/745. To ensure precautions taken during clinical investigation of investigational devices.