QualityMedDev

The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays it is something that is typically requested by any type

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

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