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 […]
Regulation (EU) 2023/1230, commonly known as the EU Machinery Regulation, is steadily approaching its full application date of 20 January 2027. We previously explored the Regulation’s main changes in our article explaining what truly differentiates it from the former Machinery Directive. In this article, we take stock of the latest developments, as the regulatory process […]
Artificial Intelligence is no longer an emerging technology. It has become one of the main drivers of global innovation and is rapidly transforming the world of intellectual property as well. A significant indicator comes from WIPO‘s (World Intellectual Property Organization) Patent Landscape Report: patent families related to generative AI increased from approximately 700 in 2014 […]
Anyone managing content in multiple languages often faces the same scenario: texts that are translated “correctly” but simply do not work, messages that lose their impact, and content that feels out of place. The problem? These are not obvious mistakes, but rather misconceptions about translation and multilingual management that are far more widespread than many […]
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 […]
A 40-foot container loaded with electronic components has been stuck at the Port of Rotterdam for three days. The reason? An error in the translation of an HS (Harmonized System) code on the customs declaration triggered an extraordinary inspection. The Chinese supplier used a different product classification from the one agreed upon, causing a hold-up […]
Generative artificial intelligence is rapidly transforming the way digital content is created. Today, advanced systems can replicate voices, images, videos, and even communication styles with an increasingly high level of realism. While deepfakes once appeared to be a niche phenomenon, they now represent a concrete issue for companies, professionals, and global brands. The rise of […]
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 […]
