Both in harmonized standards as well as in practice, there are plenty of interfaces between processes of usability, risk management and clinical evaluation. All responsible and involved employees must have knowledge about these interfaces in order to ensure an efficient process flow. The planning of chronological sequences and dependencies have great influence on the development result and also on the approval of the medical product.
PROSYSTEM has skilled experts with many years of practical experience which are in a position to implement optimal processes for you. Let your internal processes, interfaces and procedures be assessed and improved by our independent auditors.