How to Prepare IFU Translations for an MDR Audit
Under the EU Medical Device Regulation, the Instructions for Use (IFU) are no longer just supporting documentation—they are a core part of the safety information provided with the product. For Regulatory Affairs, Quality and Marketing teams, this represents a shift in mindset. A translation error
From SmPC to EMA Approval: 5 Steps to Risk-Free Pharmaceutical Translation
In the European regulatory environment, precision is not just a matter of linguistic quality—it is a compliance requirement. An error in the translation of a Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), or labelling can trigger requests for clarification during the review process by the
The future of audiovisual content in Life Sciences: accessibility as a strategic challenge
Audiovisual accessibility is no longer an emerging trend in the healthcare sector. Since 2025, it has become a strategic imperative. The entry into force of the European Accessibility Act (EAA) has fundamentally reshaped the landscape for pharmaceutical, biotechnology and MedTech companies operating across Europe. What
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.
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How to Prepare IFU Translations for an MDR Audit
Under the EU Medical Device Regulation, the Instructions for Use (IFU) are no longer just supporting documentation—they are a core part of the safety information
