Terumo BCT, Ltd.

Conformity of devices in accordance with the QMS under which the devices are manufactured and before a device is released; Compliance of devices used for clinical investigation is documented; Comply with requirements for submission of vigilance reports; Comply with PMS obligations in accordance with the manufacturer PMS system; Ensure reporting obligations are fulfilled as to analysing and reporting of serious incidents, FCSA, trend reporting, analysis of serious incidents and vigilance data.