EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices’ regulations, has published a guidance document dedicated to the integration of the UDI within an organization’s quality management system. Table...
EU MDR/IVDR The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems. The MDCG...
Asia The Health Sciences Authority (HSA), Singapore’s agency responsible for regulations in the sphere of healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. Table of Contents Apart from the...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the unique device identification system. In particular, the document is...
Asia The Health Sciences Authority (HSA), Singapore`s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The latest version of the...
