Bio-Rad Laboratories, Inc.

Ensuring the technical documentation and the EU DoC are drawn up and kept up-to-date. - Approval of CE IVD technical files - Approval of EU DoC Ensuring compliance to reporting of adverse events and field safety actions. - Approval of adverse event reports - Approval of field safety action reports In the case of interventional clinical performance studies or other performance studies involving risk for the subjects, person that can sign a statement to the safety of the subjects.

Ensuring the technical documentation and the EU DoC are drawn up and kept up-to-date. - Approval of CE IVD technical files - Approval of EU DoC "Ensuring compliance to reporting of adverse events and field safety actions. - Approval of adverse event reports - Approval of field safety action reports In the case of interventional clinical performance studies or other performance studies involving risk for the subjects, person that can sign a statement to the safety of the subjects.

Ensure post-market surveillance obligations are complied with in accordance with Article 10(9). - Approval of PMS plans - Approval of PMS reports - Approval of periodic safety update reports.

The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.