Introduction EU Regulation 2017/746 (IVDR) is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union. It was published in April ’17 and is closely aligned to the EU regulation on medical devices. The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate … Learn More
What Is Software Localization And Why It’s Essential Software Localization involves adapting software to a country’s language, cultural, and regulatory situation. Visible sections of the software such as the user interface (UI), user experience (UX), and images will be the areas that usually require localization efforts. According to CSA Research, 76% of global consumers prefer … Learn More
Website localization or website translation is the process of modifying an existing website to make it accessible, usable and culturally suitable to a target audience. Currently over 1/3 of all internet users are non-native English speakers and studies show visitors are likely to stay on a site twice as long if the website is in … Learn More
Building upon our previous discussion on recruitment strategies for Cognitive Debriefing (CD), we now transition to the meticulous preparation required for the interviews. This stage is pivotal as it lays the groundwork for the entire Cognitive Debriefing process, ensuring that the sessions are productive and the data gathered is of the highest quality. Preparing for … Learn More
Introduction In today’s rapidly evolving world of medical clinical research, the requirement for precise and reliable translation services is greater than ever. Here’s a link to a Blog titled “Making Medical Translation A Differentiating Factor For Successful Clinical Trials” that delves into this issue in full detail. With the recent advances in Artificial Intelligence (AI), … Learn More
Continuing from our discussion on the best practices for conducting Cognitive Debriefing (CD), let’s delve into the crucial first step of this process: the recruitment of participants. This phase sets the tone for the entire Cognitive Debriefing process, and effective recruitment strategies are key to gathering valuable insights from a representative sample of the target … Learn More
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