Bio-Rad Laboratories, Inc.

Ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. Ensuring compliance to reporting of adverse events and field safety actions. 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 that 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. Ensuring compliance to post-market surveillance obligations.