St. Jude Medical

• Ensuring technical documentation and EU DoC are drawn up & kept up to date. • Ensuring that, in the case of investigational devices, the documentation includes a signed statement, by the natural or legal person responsible for the manufacture of the investig. device,that the device in question conforms to the GSPRs apart from the aspects covered by the clinical investigation and that,with regard to those aspects, every precaution has been taken to protect the health & safety of the subject.

• Ensuring that the conformity of the devices is appropriately checked, in accordance with the Abbott Atlanta QMS, before a device is released. • Ensuring compliance with post-market surveillance obligations. • Ensuring the fulfilment 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.