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Mastering Japanese LQA presents a formidable challenge due to the intricacies of both the language and culture. However, for those who can overcome these challenges, the potential for business success is immense. Consider the following key factors:  Japan stands as the world’s third-largest economy, boasting a diligent and highly educated workforce.  With a population of […]

When releasing medical devices in the European market, manufacturers face many complex rules to ensure compliance with the EU’s health, safety and environmental regulations. Notified Bodies play a key function when it comes to compliance, but what do they really do? Let’s take a closer look at these accredited bodies, learn more about their role […]

In the life sciences sector, digital platforms and the shift towards patient-centered care have made multilingual marketing an indispensable tool for engaging with diverse patient populations and ensuring accessibility worldwide. Creating multilingual content that’s not only linguistically accurate but also meets the cultural and regulatory frameworks of each target market is vital. As the industry […]

EUDAMED, the European Database on Medical Devices, is a central part of the EU’s medical device regulatory landscape. This centralized hub houses critical information about medical devices circulating in the EU market, including details about their makers, safety assessments, and more. For medical device manufacturers (MDMs), understanding EUDAMED is essential. It’s not just about fulfilling […]

Manufacturers of in vitro medical devices who may be anxious over looming deadlines posed by Europe’s regulations have been given some breathing room. In January 2024, the European Commission proposed a new extension for compliance with the In Vitro Diagnostic Medical Devices Regulation IVDR) with the aim of preventing potential supply disruptions. Under the proposal […]

As we move into 2024, the Life Sciences sector in Europe and the UK continues to face a dynamic and challenging regulatory environment. The EU Medical Device Regulation (MDR), effective since May 26, 2021, and the ongoing impacts of Brexit, the United Kingdom’s 2020 exit from the European Union, remain central issues. These changes are […]

As the life sciences industry continues working to comply with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), the role of translation has never been more important.   Both the MDR and IVDR introduce detailed requirements for medical devices, including a major emphasis on language and clear instructions. Not only […]