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EUDAMED, the European Database on Medical Devices, is a central part of the EU’s medical device regulatory landscape. This centralized hub houses critical information about medical devices circulating in the EU market, including details about their makers, safety assessments, and more. For medical device manufacturers (MDMs), understanding EUDAMED is essential. It’s not just about fulfilling […]

Manufacturers of in vitro medical devices who may be anxious over looming deadlines posed by Europe’s regulations have been given some breathing room. In January 2024, the European Commission proposed a new extension for compliance with the In Vitro Diagnostic Medical Devices Regulation IVDR) with the aim of preventing potential supply disruptions. Under the proposal […]

As we move into 2024, the Life Sciences sector in Europe and the UK continues to face a dynamic and challenging regulatory environment. The EU Medical Device Regulation (MDR), effective since May 26, 2021, and the ongoing impacts of Brexit, the United Kingdom’s 2020 exit from the European Union, remain central issues. These changes are […]

As the life sciences industry continues working to comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), the role of translation has never been more important.   Both the MDR and IVDR introduce detailed requirements for medical devices, including a major emphasis on language and clear instructions. Not only […]

Whether you are conscious of it or not, design has a tremendous effect on our daily life: What captures our attention, how long an item holds our interest, how well we comprehend a message. In fact, we think legendary industrial designer Charles Ames said it best:  “The role of the designer is that of a […]

Medical device manufacturers (MDMs) have various resources to ensure compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Recently, the EU extended these deadlines, giving manufacturers more time for compliance. For instance, conformity assessments for higher-risk devices (class IIb and class III) are now due in 2027, while lower-risk devices […]

In an increasingly globalized healthcare landscape, the importance of accurate and effective language translation cannot be overstated, particularly in the life sciences sector. With this focus, Argos Multilingual recently convened a distinguished panel of experts for a webinar entitled “Building and Growing Language Operations in Life Sciences.“ The panel delved into the intricacies and challenges […]