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505
Last entries
20/11/2025
Medical devices
Context and main objective of the MDR and IVDR regulations Since their adoption in 2017, the European MDR (2017/745) and IVDR (2017/746) regulations have had a major impact on the regulatory landscape for medical devices and in vitro diagnostics. Their main objective? To enhance patient safety, ensure market transparency, and modernise compliance requirements for health technologies. Difficulties...
04/12/2025
Translation
The International Organization for Standardization (ISO), founded in 1947, is the world's leading body in the creation of standards that ensure the quality, safety, and efficiency of products and services. One of its most recognised standards is ISO 9001, the quality management system applicable to any type of organisation that wishes to continuously improve its processes and consistently meet...
27/11/2025
AbroadLink News, Medical devices
[TOC] Medica 2025: an unmissable global event for professionals in the medical sector The Medica 2025 trade fair, held in Düsseldorf, once again brought together the world’s leading players in the healthcare sector. As a key reference for healthcare and medical technology professionals, this annual event hosted over 5,000 exhibitors and around 90,000 visitors from all over the world. From cutting...
24/11/2025
Translation
The International Organization for Standardization (ISO), founded in 1947, is the world’s leading body in the creation of standards that ensure the quality, safety, and efficiency of products and services. In the healthcare and medical devices sector, ISO 13485 sets the requirements for a sector-specific quality management system, ensuring that processes comply with the most stringent...
17/11/2025
Translation
The International Organization for Standardization ( ISO ), founded in 1947, is the most recognised international authority for establishing standards that ensure quality, safety, and efficiency in products and services worldwide. In the field of professional translation, this organisation defines specific standards that allow agencies to offer a reliable, documented service in accordance with...
10/11/2025
Medical devices
Too few Notified Bodies in Europe despite the increase in CE marking applications. Analysis of the 2021-2025 figures and outlook up to 2028. [TOC] Introduction: the paradox of growing demand versus limited supply Since the MDR and IVDR came into effect, all medical device manufacturers are required to go through Notified Bodies (NB). Each device or device family must be certified compliant with...
03/11/2025
Project Management, Translation
The world of professional translation is built on a delicate balance between freelance translators and translation agencies . Both play a key role in ensuring that all kinds of content, such as technical texts , are properly adapted to different languages and cultures. However, many are unaware of how the collaboration between freelance translators and agencies actually works. In this article, we...
30/10/2025
AbroadLink News, Medical devices
AbroadLink takes part in the 4th TEAM PRRC Congress in Rome, reaffirming its support for PRRCs and medical device compliance across Europe. [TOC] What is TEAM-PRRC and what does it do? TEAM-PRRC is a European non-profit organisation founded in 2020, dedicated to the profession of “Person Responsible for Regulatory Compliance” (PRRC), as described in Article 15 of Regulation (EU) 2017/745 “MDR”...
27/10/2025
Language Technology, Translation
While translations generated by public AI tools may appear cost-effective, they often cause professionals to lose valuable time. Find out why only a translation agency using professional AI tools can ensure quality, consistency, and genuine cost savings. [TOC] A telling analogy: the DIY haircut Picture this: you book an appointment at the hairdresser, but before going, you decide to cut your own...
23/10/2025
Medical devices
Discover the latest European regulatory developments (2025/1234) on e-IFUs and their impact on the translation of medical device user manuals. Manufacturers, PRRCs and QARA professionals: everything you need to know to maintain compliance. [TOC] 1. What is an e-IFU and what is the reason behind this regulatory change? Definition: e-IFUs (electronic Instructions for Use) are digital versions of...