Skip to content Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you! Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management. Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks? Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.