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28/07/2025
Medical devices, Project Management
According to the EU Medical Device Regulation (MDR) language requirements , manufacturers must provide clear and localized Instructions for Use (IFUs) for each relevant market. While necessary for compliance, multilingual IFUs can represent a significant portion of the documentation budget, especially for companies operating across multiple jurisdictions. Below are five practical strategies to...
09/06/2025
Medical devices, Translation
One of the main objectives of Regulation (EU) 2017/745 on medical devices (MDR) is to enhance patient safety through a uniform market surveillance system. However, it is precisely in the application of these regulations where a significant problem arises: the conceptual ambiguity and confusion between the terms 'adverse event' and 'serious incident'. This terminological inconsistency is more than...