Dispositifs médicaux — Exemples d'application du processus de gestion des risques aux systèmes de remplacement et de réparation des valves cardiaques

This document illustrates the implementation of the risk management process to the total product life cycle of cardiac valve replacement and repair systems. It provides specific examples of how risk management requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems. The informative examples included herein are not exhaustive.