PSUR in EU MDR: Signal Detection Process & Challenges

Signal detection and risk management are new to medical devices. As PSUR reports for high-risk devices will be needing Signal Detection, manufacturers need to gear their processes Though the processes and methods are well
established in BioPharma, some of the areas that worked for those products may not work or applicable to Devices.

This process is a key area for companies in safety surveillance and benefit-risk monitoring of Medical Devices