European Database on Medical Devices (EUDAMED): Objectives
European database on medical devices (EUDAMED) is the European Commission’s centralized IT system for medical device and IVD regulation. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED serves as the digital...
Introduction to EU Medical Device Regulation (MDR): Key Terms
European Union Medical Device Regulation (EU MDR) 2017/745 is a framework governing safety and performance of medical devices in EU. It came into full effect on May 26, 2021, replacing the previous Medical Device Directive (MDD). It aims to address gaps in oversight...
10-Step Guide to Hassle-free Integration of UDI into QMS
Integrating unique device identification (UDI) into your quality management system (QMS) will enhance traceability, compliance, and operational excellence. UDI will improve efficiency of the medical device supply chain as well as enhance patient safety and post-market...