Life science translation
expertise

Medical device manufacturers who make their products available to users in EU Members States must meet stringent language requirements set out by the European Union Medical Devices Regulation (EU MDR) for the information supplied with their device. In this article, we break down the critical aspects of those translation requirements for labels and discuss effective practices for ensuring compliance, patient safety, and market success.

The popularity of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) is rapidly rising, with an estimated one in four medical devices now relying on software. For manufacturers aiming to penetrate the European Union (EU) market, translating the graphical user interface (GUI) of their medical device software is essential for ensuring regulatory compliance as well as user engagement across the diverse linguistic landscape of Europe. Building on our previous discussion on the EU MDR language requirements for GUIs, this article explores the practical aspects of translating GUIs of software applications made available to users across...Read more

Pal International, a global leader in infection control products, and Mastermind Translations, a specialised language service provider for life science industries, are pleased to announce their strategic partnership aimed at supporting Pal International’s presence in over 50 overseas markets.

As innovative technologies continue to revolutionise healthcare, software has become an indispensable part of many solutions, with as many as one in four medical devices now relying on it. Whether it is software in a medical device (SiMD) or software as a medical device (SaMD), the incorporation of a user-friendly graphical user interface is essential for enhancing usability and functionality. Against this meteoric rise in highly digitised medtech products, the need for clear and precise guidelines on translation for software applications is evident. However, the European regulatory framework for medical devices currently has no separate legal provisions regulating this aspect of medical...Read more

In today’s world, where diversity is celebrated and global connectivity is at its peak, translating your website is a strategic necessity that can propel your life science organization towards remarkable international success. In this article, we delve deep into the fusion of website translation and search engine optimization (SEO) to unveil the secrets of creating appealing and result-oriented multilingual content. Drawing on our own experience, we share a case study of a medtech article localized into multiple languages that has consistently stayed in the top search results.

On 17th January 2024, the European Commission released two tables summarising the language requirements for manufacturers of medical devices under the EU MDR and IVDR. These tables consolidate the national translation requirements for medical devices and in vitro diagnostic medical devices, respectively, across 31 European countries. In this article, we analyse the key aspects of this publication, its benefits and limitations, and provide insights for manufacturers aiming for compliance.

In the fast-paced world of digital marketing, multilingual search engine optimisation (SEO) has become a crucial weapon in the arsenal of successful marketing strategies for life science companies looking to expand their global reach. In today’s fiercely competitive digital environment, the translation of your life science website’s content serves as a potent catalyst to improve your online visibility, helping you better connect with your international audience. In this article, we explore the intricacies of multilingual SEO translation and localisation with a dedicated focus on the life sciences industry. From understanding the basics of SEO to the complexities of a multilingual...Read more

Are you a medical device company preparing to place your products on the European market? The new European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) introduce language translation requirements that might leave you bewildered, especially if you are new to the EU market. Navigating the intricacies of these new regulations and finding definitive answers to your questions, often very specific to your unique circumstances, can quickly become a challenging and time-consuming task for you and your regulatory team. The absence of clear guidance can lead to frustrating searches, yielding ambiguous results open to interpretation.

In the rapidly evolving landscape of medical devices, patient safety takes precedence. When issues that could potentially pose risks to users and patients arise with a medical device, manufacturers must take swift corrective action. One essential tool in this process is the Field Safety Notice, a communication mechanism used by manufacturers to inform users and customers about safety concerns regarding their products. In this article, we explore the concept of Field Safety Notices, and discuss the mandatory language requirements applicable to them under the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR). What are...Read more