Abbott Medical

• Ensuring that, in the case of investigational devices, the documentation includes a signed statement that the device in question conforms to the General Safety and Performance Requirements apart from the aspects covered by the clinical investigation and that every precaution has been taken to protect the health and safety of the subject • Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date

• Ensuring that the conformity of the devices is appropriately checked, in accordance with the Cardiac Rhythm Management QMS before a device is released. • Ensuring compliance with post-market surveillance obligations. • Ensuring the fulfillment of reporting obligations, regarding the reporting of serious incidents and Field Safety Corrective Actions, trend reporting; and analysis of serious incidents and Field Safety Corrective Actions.