Article 120 MDR: An Overview
We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article…
Field Safety Notice: What do you Need to Know?
Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers…
Electronic IFU (eIFU) for Medical Devices: Key Requirements
eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health…
