Author Archives for Katarzyna E Slobodzian-Taylor

About Katarzyna E Slobodzian-Taylor

Katarzyna E Slobodzian-Taylor — or Kasia to her colleagues — is a Life Science Translator and the founder of Mastermind Translations, a specialist provider of translation services exclusively for life science industries. With 15 years of professional experience, including an in-house translation role at the European Parliament, and over 3 million words translated, she knows her trade inside out. Her high-level translation skills and can-do attitude are the reason why so many clients choose to work with Mastermind Translations. As a Chartered Linguist, she is a strong advocate of professional standards in translation and project management. Kasia especially enjoys managing drug regulatory translation projects where her passion for the language and dedication to client success can truly shine.

Pal International and Mastermind Translations - Translation for medical device manufacturers

Pal International Partners with Mastermind Translations: A Strategic Alliance for Medical Device Translation Services

May 17, 2024 1:06 pm Published by Leave your thoughtsPal 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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MDR Language Requirements - Software GUI

EU MDR Language Requirements for the Graphical User Interface (GUI) of a Medical Device: What Are the Translation Requirements in Each EU Member State?

April 2, 2024 6:00 am Published by Leave your thoughtsAs 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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NeuronWriter - Website Translation

How Our Multilingual Website Content Got Catapulted to the Top of Google: The Secret of High Performing SEO Translation

March 1, 2024 9:30 am Published by Leave your thoughtsIn 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.
EU Commission Language Requirements for Medical Devices in Europe

Overview of Language Requirements for Medical Devices in Each Member State under the EU MDR and IVDR Published by the European Commission

February 8, 2024 3:13 pm Published by Leave your thoughtsOn 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.
Multilingual Life Science SEO Website Translation

Boosting the Visibility of Your International Life Science Website: A Comprehensive Guide to Multilingual SEO Translation and Localisation

November 24, 2023 1:58 pm Published by Leave your thoughtsIn 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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medical device translation requirements in Europe

FAQs: Language Translation Requirements for Medical Device Companies Operating in the EU under the New EU MDR and IVDR

October 19, 2023 2:46 pm Published by Leave your thoughtsAre 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.
MDR Field Safety Notice Language Requirements

What Are the MDR and IVDR Language Requirements for Field Safety Notices for Medical Devices?

August 29, 2023 11:10 am Published by Leave your thoughtsIn 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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Language Requirements for Devices in Montenegro

What Are the EU MDR Language Requirements for Medical Devices in Montenegro And How Can We Ensure Compliance?

March 31, 2023 3:38 pm Published by Leave your thoughtsMontenegro’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.
Language requirements for medical devices in Serbia

What Are the Language Requirements for Medical Devices in Serbia?

March 8, 2023 4:15 pm Published by Leave your thoughtsSerbia 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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MDR Language Requirements in Turkey

What Are the Language Requirements for Medical Devices in Turkey?

February 13, 2023 12:07 pm Published by Leave your thoughtsNearly 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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Language Requirements for Devices in Switzerland

What Are the Language Requirements for Devices in Switzerland?

January 19, 2023 2:20 pm Published by Leave your thoughtsLike 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.
déclaration de conformité UE

Dans quelles langues faut-il traduire la déclaration de conformité UE pour les dispositifs médicaux mis sur le marché de l’UE ?

December 9, 2022 1:01 am Published by Leave your thoughtsEn 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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exigences linguistiques du RDM

Quelles sont les langues acceptées dans le cadre des exigences linguistiques du RDM dans chaque État membre de l’UE ?

December 2, 2022 1:01 am Published by Leave your thoughtsLe 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.
IVDR Language Requirements for Screens and Software

What Are the EU IVDR Language Requirements for Screens and Software?

November 25, 2022 12:05 am Published by Leave your thoughtsThe value of in vitro diagnostic medical devices resides in the quality of diagnostic data they provide. The EU IVDR 2017/746 states very clearly that an in vitro diagnostic medical device must be supplied with information in an official EU language(s) chosen by the Member State in which it is made available to the user or patient. However, it is less clear whether these translation rules also apply to text appearing on the device’s screen and in software that is a device in itself. In this article, we revisit the linguistic provisions under the IVDR, and focus specifically on the...
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Sprachen für die EU-Konformitätserklärung

Welche Sprachen für die EU-Konformitätserklärung sind gemäß EU-MDR/IVDR bei Medizinprodukten erforderlich?

November 9, 2022 1:34 pm Published by Leave your thoughtsBevor Sie ein Medizinprodukt in der EU in den Verkehr bringen können, müssen Sie als Hersteller zunächst nachweisen, dass Ihr Produkt der geltenden EU-Gesetzgebung entspricht. Die EU-Konformitätserklärung ist dabei ein zentrales Dokument. Je nach EU-Mitgliedstaat, in dem Sie Ihr Medizinprodukt einführen möchten, muss Ihre EU-Konformitätserklärung möglicherweise in die Amtssprache(n) des jeweiligen Landes übersetzt werden. In diesem Artikel möchten wir Sie über die Anforderungen an die Sprachen für die EU-Konformitätserklärung informieren, die von den Verordnungen für Medizinprodukte und In-vitro-Diagnostika der EU (MDR und IVDR) gestellt werden. Ganz konkret gehen wir auch auf die Sprachen ein, die in den einzelnen EU-Mitgliedstaaten akzeptiert...
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