1) conformity of the devices is appropriately checked, in accordance with the Structural Heart QMS, before a device is released.2)signed statements of conformity for investigational and commercial devices.3)compliance with post-market surveillance obligations.4)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.
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CARLSSON Minori
Ensuring that the technical documentation and the EU Declaration of Conformity are drawn up and kept up-to-date.