In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the EU Medical Device Regulation (MDR) and Article 83 of the

IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of software-based medical devices. While these two standards may appear similar at first glance, they actually

Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the device being the primary driver of its mode of action. While we have previously discussed

ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization and issue the related ISO 13485 certificate, upon successful completion

As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction of the EU In-Vitro Diagnostic Regulation; one of these changes