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Compliance by design dispositivi medici

Compliance by Design in Medical Devices: Quality, Data and Translations

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 […]

Apostille o legalizzazione

Apostille or Legalization? Everything You Need to Know for Documents Abroad

Anyone who needs to submit documents for use abroad often faces a crucial question: is an apostille required, or consular legalization? This is not a minor detail. Choosing the correct procedure ensures that the document will be valid in the destination country and helps avoid delays, rejections, or requests for additional documentation. Understanding the difference […]

Traduzione manuali d’uso

User Manual Translation: Regulatory Obligations and Quality Criteria for Export

For companies exporting machinery or technical equipment, the translation of user manuals is a structural element of regulatory compliance and, consequently, an integral part of the product itself. Within the European and international context, technical documentation is a legal requirement and must mandatorily accompany the machine for it to be placed on the market. A […]

Emotional Perception

Emotional Perception 2026: the UK ruling that reshapes AI patent rules and the role of translation

11 February 2026 is a date that IP practitioners will remember. The UK Supreme Court issued its Emotional Perception judgment, significantly reshaping the criteria for patentability of software and artificial-intelligence-based inventions. For IP firms managing international filings, the key issue is not only the legal update itself, but understanding how this shift may affect the […]

Carico mentale delle donne

Women, Work and Mental Load: Why Multitasking Is a Myth (and How to Find Balance Again)

An interview with Valeria Chiara Puppo and Irene Bernardini, for International Women’s Day and beyond.   There’s a way to celebrate women that we like more than any other: listening to them. We met Valeria and Irene, two professionals who support many women in their journeys, and we let them speak. Valeria Chiara Puppo holds […]

Normativa dispositivi medici: MDR, IVDR e EUDAMED

Medical Device Regulation: MDR 2025 Revision, IVDR, EUDAMED and Italian Governance

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, […]

Strategia UE per il settore Life Sciences

EU Strategy for the Life Sciences Sector: the Roadmap to 2030

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 […]

Aglatech14 acquisisce Centrolingue

Aglatech14 acquires Centrolingue S.r.l.

Aglatech14 begins 2026 with a significant step in its growth journey: the acquisition of Centrolingue S.r.l., a long-established language services agency that has been operating in Padua for over 30 years. From 1 January 2026, Aglatech14 has taken over the management of Centrolingue’s language services, integrating into its team a group of professionals with extensive […]

Articles 0

The New EU Machinery Regulation: What Is Really Changing (and Why You Need to Prepare Now)

2023 marked a crucial turning point for the European industrial sector: on June 29, Regulation (EU) 2023/1230 officially came into force, set to replace the current Machinery Directive 2006/42/EC. Although its actual application is scheduled for January 20, 2027, there is not much time left to comply, especially for companies that design, manufacture, or place […]