Terumo BCT, Inc.

Primary point of contact for regulating bodies; Ensure that all regulatory documentation is prepared and maintained; Ensure that technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date; Ensure that every precaution is taken in the case of investigational devices to protect the health and safety of the subject as it relates to the conformity with the general safety and performance requirements apart from the aspects covered by the clinical investigation.

Responsible for appropriately checking conformity of devices in accordance with the QMS under which the devices are manufactured and before a device is released; Ensure 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 that the reporting obligations referred to in Articles 87 – 91 of the EU MDR 2017/745 are fulfilled.