Clinical Evaluation Plan according to EU MDR 2017/745
There is no doubt about the central role of clinical evaluation in relation to the European Medical Device and in-vitro Diagnostic Regulation; this is why having a well documented clinical
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 120 MDR, which basically regulates the transition period between the
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 of any safety-related issue related to their medical devices. It
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 and digital medical devices. We have been extensively talking about
Hemocompatibility of Medical Devices: an Overview
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with blood. It is obvious that among the whole set of
