Pal International Partners with Mastermind Translations: A Strategic Alliance for Medical Device Translation Services
17 May, 2024 Pal International and Mastermind Translations - Translation for medical device manufacturers 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. This partnership is rooted in a shared commitment to excellence, quality, and innovation. Its objective is to streamline translation workflows and ensure regulatory compliance of information supplied with Pal International’s products. Originating from Pal International’s request to translate regulatory documentation, Mastermind Translations provided not only translations but also invaluable suggestions to ensure compliance with the latest EU regulations for Class IIa...
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EU MDR Language Requirements for the Graphical User Interface (GUI) of a Medical Device: What Are the Translation Requirements in Each EU Member State?
2 April, 2024 MDR Language Requirements - Software GUI 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...
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How Our Multilingual Website Content Got Catapulted to the Top of Google: The Secret of High Performing SEO Translation
1 March, 2024 NeuronWriter - Website Translation 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.
Overview of Language Requirements for Medical Devices in Each Member State under the EU MDR and IVDR Published by the European Commission
8 February, 2024 EU Commission Language Requirements for Medical Devices in Europe 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.
Boosting the Visibility of Your International Life Science Website: A Comprehensive Guide to Multilingual SEO Translation and Localisation
24 November, 2023 Multilingual Life Science SEO Website Translation 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...
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FAQs: Language Translation Requirements for Medical Device Companies Operating in the EU under the New EU MDR and IVDR
19 October, 2023 medical device translation requirements in Europe 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.
What Are the MDR and IVDR Language Requirements for Field Safety Notices for Medical Devices?
29 August, 2023 MDR Field Safety Notice Language Requirements 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...
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What Are the Language Requirements for Medical Device Registration in Latin America (LatAm)?
23 July, 2023 Language Requirements for Medical Devices in Latin America LatAm Latin America, with its vast population of over 650 million across 20 countries, presents a rapidly growing market for medical device companies. Factors such as population growth, enhanced healthcare accessibility, and an increase in chronic diseases have fuelled rising demand for medical technologies in the region. Recent improvements in the medical device regulatory framework further facilitate market entry for medtech companies with global ambitions. To successfully navigate the local regulatory environment, manufacturers must comply with language requirements, and ensure that specific information is provided in the requested languages, such as Spanish or Portuguese. In this article, we explore the language...
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Is Your Food Supplement Compliant with Food Advertising and Labelling of Food Supplements Rules?
30 May, 2023 Food supplement advertising rules In today’s health-conscious society, the popularity of food supplements has soared. To protect consumers, preserve brand reputation, and avoid legal pitfalls, manufacturers and marketers must comply with labelling and promotional regulations. Getting your copy right from the start is also vital, to prevent misleading information being reproduced in translation. In this article, you will learn how to ensure regulatory compliance for your product information and its promotional material.
What Are the EU MDR Language Requirements for Medical Devices in Montenegro And How Can We Ensure Compliance?
31 March, 2023 Language Requirements for Devices in Montenegro Montenegro’s progress towards full membership of the European Union has led to the harmonisation of many of its laws with EU legislation, including medical device legislation. The marketing of medical devices is subject to particularly stringent regulatory measures in the EU market, which has recently seen the introduction of new mandatory language requirements for product information, such as labels and instructions for use. This article aims to provide insights into the language requirements for medical devices in Montenegro and their implications for medical device companies intending to enter the Montenegrin market.
What Are the Language Requirements for Medical Devices in Serbia?
8 March, 2023 Language requirements for medical devices in Serbia Serbia is making significant progress towards membership of the European Union and, as part of this process, has harmonised a number of its laws and regulations with EU legislation. One such legal area concerns the marketing of medical devices. This is subject to stringent regulatory measures, including mandatory language requirements for the product information accompanying the medical device, such as the label and instructions for use. As a result, manufacturers of medical devices intending to place their products on the Serbian market must follow strict language rules. This article will explore the language requirements for medical devices in Serbia and...
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What Are the Language Requirements for Medical Devices in Turkey?
13 February, 2023 MDR Language Requirements in Turkey Nearly 80% of medical devices in Turkey are imported, with as many as half of those imports coming from the European region. While still a candidate for EU membership, Turkey has developed a strong trading relationship with the EU spanning nearly three decades, in order to facilitate the movement of medical technologies into its market. This relationship relies heavily on the alignment of Turkish medical device legislation with that of the EU. The scope of this harmonisation also covers the language requirements for medical devices in Turkey. In this article, we discuss the linguistic rules for manufacturers and importers of...
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What Are the Language Requirements for Devices in Switzerland?
19 January, 2023 Language Requirements for Devices in Switzerland Like many other European countries, Switzerland strongly relies on imports to meet a growing demand for innovative medical devices. In order to facilitate international trade, the country has aligned its medical devices legislation with the EU MDR and the EU IVDR. This harmonisation also covers language requirements for information supplied with medical devices placed on the trilingual Swiss market. In this article, we discuss key provisions for the mandatory language requirements for devices in Switzerland, and what they mean for manufacturers and importers.
Dans quelles langues faut-il traduire la déclaration de conformité UE pour les dispositifs médicaux mis sur le marché de l’UE ?
9 December, 2022 déclaration de conformité UE En qualité de fabricant, avant la mise sur le marché européen de votre dispositif médical, vous devez d’abord démontrer que votre produit est conforme à la législation européenne en vigueur. La déclaration de conformité UE est un document incontournable de ce processus réglementaire. Selon l’État membre où votre dispositif médical sera mis à disposition, la déclaration de conformité devra être traduite dans la ou les langues officielles du pays en question. Dans cet article, nous examinons les exigences linguistiques imposées dans les textes réglementaires s’appliquant aux dispositifs médicaux (DM) et aux dispositifs médicaux de diagnostic in vitro (DMDIV) s’agissant de la...
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Quelles sont les langues acceptées dans le cadre des exigences linguistiques du RDM dans chaque État membre de l’UE ?
2 December, 2022 exigences linguistiques du RDM Le nouveau règlement européen relatif aux dispositifs médicaux (RDM) resserre les contraintes entourant la commercialisation des dispositifs médicaux sur le marché européen. Il exige en effet que chaque État membre de l’Union européenne définisse la ou les langues dans lesquelles un dispositif est mis à disposition. Dans cet article, nous présentons les langues acceptées dans chaque État membre conformément aux exigences linguistiques du RDM.