How the EU AI Act is Reshaping Innovation in Healthcare Products
The healthcare product sector is experiencing a technological transformation like never before. Algorithms analysing radiology images, natural language models summarising complex clinical records—the use of artificial intelligence (AI) is no longer a future promise but a central driver of operational efficiency. Yet the introduction of
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
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.
Understanding Med-PaLM: Google’s Generative AI in Healthcare
Med-PaLM, a groundbreaking large language model (LLM) developed by Google, signifies a significant advancement in the application of artificial intelligence (AI) within the healthcare sector. Trained specifically with a vast corpus of medical data, Med-PaLM aims to revolutionize the way medical professionals access and interpret
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
Globalizing Smiles: Dentistry and Localization
A healthy picture-perfect smile has become a top priority and a beauty standard across the globe, partly motivated by celebrities and the vanity culture developed with social media. However, worldwide we can witness an increase in the prevalence of dental disorders due to smoking, aging,
How to adapt your digital health solutions for overseas markets and local audiences
Digital is the future of Health Care Almost everything we do these days has gone digital, and healthcare has been no exception. With more than 5.07 billion internet users in the world, healthcare providers now see a clear potential for data-driven insights to improve how
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
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How the EU AI Act is Reshaping Innovation in Healthcare Products
The healthcare product sector is experiencing a technological transformation like never before. Algorithms analysing radiology images, natural language models summarising complex clinical records—the use of
