In the realm of medical imaging, DICOM (Digital Imaging and Communications in Medicine) files are indispensable. These files store and transmit information related to medical imaging, ensuring that patient data, diagnostic images, and other critical information are accurately captured and shared across healthcare systems. As medical facilities increasingly rely on DICOM files, the need for … Learn More
Introduction In January 2024 the European Commission decided to delay some elements of IVDR. But, to protect patient care and safety they at the same time agreed to speed up the launch of some parts of the European Database on Medical Devices (EUDAMED). What Is EUDAMED EUDAMED is the IT system established by IVDR, and … Learn More
Introduction The European Union Medical Device Regulation (MDR) adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EMA and for national authorities in the assessment of certain categories of medical products. The aim of the MDR is to ensure patient safety and provide greater transparency and traceability … Learn More
Introduction In a recent blog post titled Complying with European In-Vitro Diagnostic Regulation (IVDR) Language Translation Requirements, we described what this is regulation is and its intent. In summarizing, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold. When enacted … Learn More
OPI also helps medical facilities, legal institutions and companies meet local, state, federal and international mandates for requiring high-quality interpreters, and are a lifeline at times of Emergency, when accurate information is important to deliver the right help quickly. So, not only is OPI an important translation service to have on-hand, but having 24/7 availability of this service is essential.