Risk management (ISO 14971)
Short definition
Risk management is the continuous process of identifying the hazards of a medical device, estimating and evaluating the risks, controlling them and monitoring the effectiveness of those controls, according to the ISO 14971 standard.
In plain language
Regulation (EU) 2017/745 requires all manufacturers to have a risk management system covering the device's whole life cycle, and ISO 14971 (2019 edition) is the reference standard for doing so. It covers risks as varied as electrical, usability or data security risks. In virtual reality, for example, cybersickness and falls are risks to be considered.