The new EU MDR implementation is causing changes to the translation requirements of CE Markings. Previously, technical documents that required CE marking did not require translation pre-approval. Under the MDR, however, documents that receive CE markings like labelling, instructions for use (IFUs), and patient information documents must be translated into the official languages of each country. Further, countries may designate additional languages required for diverse populations within the country. Accurate translation that is “clear and precise” is necessary across all official languages and is essential in ensuring that regardless of who is reading the material, it is understood entirely and effectively. For companies that fail to comply with CE Marking, it can mean a potential investigation from the local regulatory body, causing delays in the production timeline and ultimately losing revenue.
CSOFT provides highly accurate CE Marking translations for life science companies expanding overseas. With an extensive network of over 10,000 in-country linguists and subject matter experts, we understand the importance of timely and accurate CE mark translations.
Medical Device Translation
CE Marking is a requirement for all medical device products, from in-vitro diagnostic medical devices to active implantable medical devices, in gaining market access and complying with local regulatory requirements. For medical device companies expanding into the EEA market, accurate translation is necessary in gaining CE Marking, particularly under the new MDR.
Learn more about our medical device translations.
High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.
Learn more about our quality assurance process.
CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and ISO 17100:2015, and leverage best practices from ISO 27001.
Learn more about how CSOFT protects companies’ data.