What is the purpose of developing a medical device? If you ask your employees, the probable answer is that it is to help patients and fulfill user needs. Which is fair enough, but in order to do that we also need to understand that regulatory and government authorities also are included in the “user needs”. […]

Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI, […]