We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article 120 MDR, which basically regulates the transition period between the

Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers of any safety-related issue related to their medical devices. It

eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health and digital medical devices. We have been extensively talking about