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The Risks of Using AI in Regulatory Dossier Translation: Hallucinations and Critical Errors

AI is rapidly reshaping how life sciences organisations work — and translation is no exception. Faced with ever-growing submission volumes, compressed timelines and global programmes that rarely run sequentially, many Regulatory Affairs teams are understandably asking the same question: can AI help us translate faster, and still submit with confidence? The short

An MDR/IVDR Text Map: What May Need Translating in the EU (and How to Plan It Without Improvising)

In Life Sciences, gaining access to the European market is no longer only about innovation, clinical evidence and manufacturing capacity. With MDR and IVDR now firmly embedded, the linguistic dimension has become a real part of regulatory compliance. And this is not about cultural diversity; it is

5 hybrid strategies: machine translation + human review for healthcare regulatory compliance

Healthcare and Life Sciences companies are under growing pressure. Demand for language services in this sector is rising by around 9.5% per year, driven by regulations such as the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The result? Large volumes of

7 critical mistakes to avoid when translating IFUs and medical product labelling

Regulatory Affairs professionals operate under constant pressure from regulations such as the MDR and IVDR, which have turned documentation into a critical component of the medical product itself. The risk of non-compliance during an audit — and the regulatory, commercial and legal consequences that may follow — is a daily reality.

Specialist Translation in Clinical Trials: A Strategic Asset for CROs

Delivering a global clinical trial successfully is a complex operational challenge. For a Contract Research Organisation (CRO), the focus is firmly on execution: coordinating multiple stakeholders, countries, investigative sites and vendors while maintaining control over timelines, quality and compliance. Unlike sponsors, CROs are not measured by the commercial return of the asset, but

How to Design a Translation Workflow Compliant with MDR and ISO 13485 in 5 Steps

Regulatory and Quality leaders in the medical device industry face a significant challenge: meeting the demanding linguistic requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) ahead of their respective 2028 and 2027 deadlines. This means translating documentation into as

Using AI for Translation: Stay MDR-Compliant

Are you using Machine Translation or AI to translate medical device documentation? Wondering whether that could lead to non-compliance with Regulation (EU) 2017/745 (MDR)? Here’s what you need to know.

The importance of ISO 17100 when choosing a translation partner

Choosing a translation partner can be a challenging undertaking. You want a partner with an established quality assurance process, expertise in the languages you need, strong data security protocols, a responsive project management team, and last but not least a company that can meet your

New deadline for the certification of medical devices under the Medical Devices Regulation (MDR)

On 7 March 2023, the Council adopted a regulation that extends the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). The measure aims to allow the MedTech industry to continue to bring essential equipment to the market and ensure that

Certified Translation of Instructions for Use for Medical Devices

The primary objective of the translation is to provide users with clear and understandable guidelines for properly using medical devices. The most important aspect to keep in mind involves legal issues. Countries in the European Union dictate that the proper translation of instructions of use