Online education has been evolving at a rapid pace. E-learning videos have gone from a nice add-on to an indispensable tool for disseminating knowledge and engaging learners. As the world becomes more interconnected, catering to a diverse and global audience has...
The In Vitro Diagnostic Regulation (IVDR) is a new set of regulations introduced by the European Union (EU) to ensure the safety and performance of in vitro diagnostic medical devices (IVDs). These devices, which include everything from pregnancy tests to blood...
Navigating MDR & IVDR Compliance: Streamlining Localization with TrueLanguage For medical device manufacturers, it is crucial to understand and comply with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation IVDR for your products. These...
The Global Harmonization Task Force (GHTF) does not directly affect translation companies since its primary focus is on regulatory harmonization and standardization of medical device regulations. However, the work and initiatives of the GHTF indirectly impact...
What exactly is the EU MDR? The European Union’s Medical Device Regulation (EU MDR) was a significant update to the regulatory framework for medical devices in the EU, replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices...
