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Last entries
27/02/2026
Medical devices
Regulatory information: Google and ChatGPT versus RIM solutions (when accuracy matters) Last week, my wife (a medical student) was preparing for a multiple-choice exam in general physiology (1st year of medicine). To save time, she tried to use ChatGPT. The experience was frustrating: on many occasions, the answer changed depending on how she asked the question. Then, she turned to Google. In her...
20/02/2026
Medical devices, Translation
Following on from our previous article on what it means to have accurate, up-to-date translations that are faithful to the master version , this article describes how to manage local adaptations without compromising compliance. At first glance, adapting instructions for use (IFUs) to a local market may appear to be nothing more than a simple language localisation task. However, under the MDR and...
18/02/2026
Medical devices, Translation
For medical device manufacturers, PRRCs and QARA teams, the requirements of Regulation (EU) 2017/745 (MDR) for IFUs, labelling and accompanying documentation go beyond simply “having the correct translation”. The Regulation stipulates that the information supplied by the manufacturer must be understandable, consistent and kept up-to-date in the languages required by each Member State. The purpose...
09/02/2026
Business Management
If you are looking for a translation agency for your company, the real challenge is not finding one, but rather minimising risk (quality, deadlines, compliance, confidentiality) and ensuring scalability. This guide outlines key selection criteria, an objective evaluation matrix and a list of translation agencies by speciality . [TOC] Practical criteria for comparing agencies Specialisation...
05/02/2026
Medical devices
This article follows on from the one published on 29 January regarding the “ European Commission’s proposal for revising EU MDR and IVDR: Key points” (January 2026) and the effects that amending this proposal would have on the language aspect of the development of medical devices. Translation processes for medical devices have now taken on strategic importance, going far beyond a simple...
02/02/2026
Language Technology, Translation
The global translation industry is in the middle of its biggest disruption since the arrival of last generation of CAT tools. Language service providers, publishers and in-house teams are all asking the same question: what does artificial intelligence really change – and how fast? Market studies show that the wider language services industry was worth roughly USD 72 billion in 2024, after mid-...
29/01/2026
Medical devices
The European Commission has published a far-reaching proposal to revise the MDR 2017/745 on medical devices and IVDR 2017/746 on in-vitro diagnostic medical devices , with the stated aim of simplifying the system, reducing burden and improving availability of devices in Europe, while keeping a high level of patient safety. [TOC] What Does the New EU MDR and IVDR Revision Proposal Mean for...
26/01/2026
Medical devices
The European Commission has published a draft Implementing Regulation on the uniform application of requirements for notified bodies under the MDR and IVDR . At first glance, this may sound like a technical or procedural update. In reality, it is a significant regulatory initiative that directly affects how medical devices and IVDs are certified, how long this takes, and how much it costs across...
22/01/2026
Medical devices
Navigating the European Union Medical Device Regulation (MDR 2017/745) means mastering the alphabet soup of MDR acronyms. If you’re a medical device manufacturer navigating the EU MDR (Medical Device Regulation) , you’re already aware that the regulation is packed with acronyms. These acronyms are crucial for compliance, but they can be challenging to decipher, especially when you need to...
15/01/2026
Medical devices
For years, EUDAMED has been “the great European database” that everyone is talking about in the medical device sector. Commission Decision (EU) 2025/2371 , published on 27 November 2025, marks a decisive step for the database, as four key modules are officially declared functional, triggering the countdown to mandatory use across the European Union . For manufacturers, their QARA teams, their...