The UDI system (Unique Device Identification) has been implemented to ensure the traceability of medical devices within the European Union. Before placing a device on the market, manufacturers must: Assign a Basic UDI-DI and a UDI-PI. Place UDI carriers on the device label. Submit the information to the European database EUDAMED. Where Do We Stand […]
The introduction of the European MDR Regulation marked a turning point for medical device manufacturers, placing the generation and collection of clinical evidence and data at the core of the regulatory process. By 2024, the MDR is no longer considered a “new regulation” but rather an established system requiring precise methodological approaches and targeted strategies […]
According to Enrico Perfler, CEO of 1Med SA, a consultancy specializing in regulatory affairs, there is an increasingly evident trend among medical device manufacturers favouring the United States over Europe for conducting clinical investigations. This preference reflects significant differences in regulatory systems and market dynamics, as highlighted during his presentation at the AboutMedicalDevices conference. Manufacturers’ […]
MedTech Europe is the leading European association for the medical technology sector, including diagnostics, medical devices, and digital health. During the AboutMedicalDevices conference, Merlin Rietschel, Senior Manager of Medical Devices, Industrial Policies, analysed the state of the European medical devices industry through a survey conducted among medical device manufacturers, highlighting issues related to the implementation […]
The medical device sector in Italy is facing more complex challenges than other European countries. Despite a market valued at €12.4 billion—split 75% in public healthcare and 25% in private healthcare—and a 6.9% growth rate, 2022 saw a 30% drop in research and development investments. It remains unclear whether this situation is temporary or structural, […]
25The translation of medical device content is a highly specialized field requiring advanced linguistic skills and a deep understanding of international regulations. In this context, linguistic precision is critical, as even minor inaccuracies can compromise patient safety and device effectiveness. Translations must strictly adhere to medical regulations, such as those established by the FDA in […]
In today’s global landscape, marketing translations are essential for companies aiming to expand their international presence. A key aspect of this expansion is the ability to communicate effectively across cultures and languages without compromising authenticity or brand identity. In this article, we’ll explore the pros and cons of using AI for marketing translations, highlighting how technology […]
In the digital era, video content creation is experiencing tremendous growth, but there is one crucial aspect that is often overlooked: accessibility. Making videos accessible means ensuring that every person, regardless of their linguistic or hearing abilities, can understand and appreciate the message you wish to communicate. Multilingual subtitles are essential: they not only […]
Aglatech14 is an Italian LSP specializing in translations for intellectual property, as well as for the legal, technical, and medical-scientific sectors. It ranked first among Italian agencies in the Boutique category of the 2024 Slator international ranking (LSPI – Slator Language Service Provider Index). Following the recent passing of CEO and founder Giacomo Grassi, who […]
How important are subtitles in SEO? Or rather, how can subtitling affect the SEO of a video? Video subtitles offer SEO benefits that shouldn’t be underestimated. Whether by improving the user experience, extending viewing time, or amplifying global reach, adding subtitles to video content is a winning strategy to improve search engine visibility. That’s why […]
