Safety is of paramount importance when it comes to medical devices. These devices are designed to save lives, improve health, and aid in diagnostics; hence, they must adhere to the highest standards. ISO 14971 risk management for medical devices serves as an internationally recognized standard for risk management pertaining to medical devices. This standard outlines the best practices for identifying, evaluating, and controlling risks throughout the lifecycle of a medical device. The aim is not just to make the device safe but also to ensure that the benefits far outweigh the risks. See here: https://tlm-software.com/