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...
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...
Medical device translations are a critical aspect of the healthcare industry. They ensure that important information related to the use, maintenance, and safety of medical devices is available to users in different languages. However, medical device translations are...
The medical device industry is highly regulated and demands precise and accurate translations to ensure patient safety and compliance with regulatory requirements. To reach a wider audience, medical device companies with global operations must translate their...
We’ve blogged in the past about the challenges and particularities of managing translation projects for different branches of our client base. Then, as now, the lion’s share of our workload consists of technical translation. Manuals, packaging, training programs and...