CE marking Translations
We provide high-quality CE marking translations and communication services of technical documentation for life science companies marketing in the EEA.
Access European Markets with CE Marking Translations
CE Marketing Translations allow life science companies to market medical products throughout Europe and across languages. The CE marking, sometimes referred to as the CE mark or the European Trade Passport, signifies that a product is verified and compliant with consumer and environmental protection standards regarding public health and safety for the European Economic Area (EEA). The term CE Marking stands for “Conformité Européene” in French, which translates to European Conformity. The EEA is comprised of the 27 EU member states as well as Iceland, Liechtenstein, and Norway, making CE marking imperative for any products manufactured, marketed, or produced in a large and extremely diverse market. While CE marking is not a quality assurance step, it is a mandatory safety marking that demonstrates conformity to directives.
CSOFT Health Sciences 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 Regulation (MDR) Translations
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. Combining our vast network of in-country professional linguists and medical subject matter experts, advanced language technology, and localization best practices, CSOFT Health Sciences enables EU market access for medical device companies across all 24 official languages of the EU.
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Medical Device Translations
CE marking is a requirement for all medical device products, from in vitro diagnostic medical devices to active implantable medical devices, in gaining European market access and complying with local regulatory requirements across countries. For medical device companies expanding into the EEA market, accurate translation is necessary in gaining CE marking, particularly under the new MDR.
Combining our advanced cloud-based language technology and expert human linguists, CSOFT Health Sciences delivers the highest-quality medical device translations that are cost-effective with quick turnaround times.
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CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
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With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.