In 2026, Aglatech14 is once again included in the CSA Research Verified 100, the annual ranking of the world’s top 100 translation agencies and language service providers. CSA Research is an independent research firm specialising in the translation, localisation, and language services industry. Each year, it publishes the Global Market Study, which analyses hundreds of […]
When people think about packaging, they almost always picture consumer products: aesthetics, branding and shelf appeal. In the world of medical device packaging, however, the perspective is completely different. The packaging is not an accessory but an integral part of the device itself. It must preserve sterility, withstand transportation, communicate critical information within just a […]
The year 2026 marks a turning point for the medical device sector. As of this year, EUDAMED is fully operational for its first four modules, the European Commission has presented its proposal to revise the MDR and IVDR Regulations, and national databases are evolving towards increasingly integrated governance-oriented architectures. Completing this picture, artificial intelligence has […]
The global clinical research landscape is evolving rapidly, and Europe has no intention of standing still. While the United States and Asian countries continue to attract an increasing share of multinational studies, European institutions have launched a structured and ambitious response: a two-year plan designed to transform Europe into a more efficient, harmonized, and attractive […]
In the medical device industry, labelling is not merely a regulatory requirement, but a fundamental element in ensuring product safety, traceability and proper use. With the entry into force of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), labelling has taken on an even more strategic role, particularly for companies operating across multiple European […]
Artificial intelligence has revolutionized the translation industry in recent years, making previously unimaginable tools accessible. However, with the European AI Act coming into force in August 2024, the regulatory landscape is changing radically. The world’s first comprehensive regulation dedicated to artificial intelligence is not merely a technical matter: it redefines responsibility, transparency, and security for […]
In the context of Regulation (EU) 2017/745 (MDR), the concept of Technical Documentation has undergone a profound transformation with the MDR Product Record. It is no longer a static set of documents to be submitted for CE marking, but a dynamic system that accompanies the device throughout its entire lifecycle. Today, for medical device manufacturers, […]
In the medical device sector, regulatory compliance can no longer be considered an activity to be addressed only in the final stages of development. International regulations, from the European MDR Regulation to FDA requirements, demand that safety, quality and traceability be integrated throughout the entire product lifecycle, from design to commercialization. For this reason, an […]
Medical device regulation in Europe is undergoing a significant phase of evolution, with direct impacts on the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Several years have now passed since the MDR and IVDR became applicable; however, while the European regulatory system can no longer be considered in its start-up phase, […]
In this article, we analyse the European Union’s strategy for the Life Sciences sector and the roadmap to 2030, exploring investments, innovation policies, regulatory simplification and digital interoperability, with particular attention to the strategic role of compliant and professional multilingual communication for companies operating in the European market. The European Union has outlined an ambitious […]
