Exact Diagnostics

Ensure technical documentation and EU declaration of conformity are drawn up approved and kept up-to-date. Ensure compliance to reporting of adverse events and field safety actions and approval of these 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 conformity of devices is appropriately checked in accordance with the quality management system under which the devices are manufactured, before a device is released. Approval of batch records and/or travelers, product packaging and QC procedures, of significant deviations to production and QC procedures Ensure compliance to post-market surveillance (PMS) obligations. Approval of PMS plans, report and periodic safety update reports