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After our rewarding experience last year in Málaga , AbroadLink Translations is excited to announce our sponsorship and participation at the TEAM-PRRC 4th Annual Summit 2025 , taking place in Rome, Italy, on October 23–24, 2025 . This leading European regulatory affairs event has become a cornerstone for professionals working with medical devices, in vitro diagnostics, and MDR/IVDR compliance ...
At AbroadLink Translations, we are delighted to announce the successful renewal of our ISO 9001, ISO 17100, and ISO 13485 certifications. This achievement demonstrates our unwavering commitment to quality, accuracy, and compliance in Life Sciences translations, particularly in the highly regulated field of medical devices in Europe. [TOC] A Strong Commitment to Quality and Compliance For...
Every year, the MEDICA trade fair in Düsseldorf brings together the most influential stakeholders in the global medical industry. From 17 to 20 November 2025, more than 5,000 exhibitors and 80,000 professional visitors from 165 different countries are expected to attend. It is the ideal opportunity to present your innovations, forge strategic partnerships and enhance your brand's visibility in...
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...
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...