July 2011 marked an important milestone for Berlin Heart GmbH. The advisory council of the US Food and Drug Administration (FDA) unanimously agreed that the EXCOR® Pediatric cardiac support systems be approved for use in the USA. Berlin Heart had laid its trust in CAQ AG’s software solutions in order to be able to convince the FDA of the high standards of quality employed in its products and processes. The head of IT at Berlin Heart, is convinced that “Approval for use in the USA would not have been possible without the implementation of a consistent CAQ-System”.