EU MDR Translation Services
Our industry expert linguists are an extension of your team
Language Scientific has been providing medical device translation services for medical device companies for over 20 years in over 215 languages. We are a leader in enterprise MDR translation services and our team of MDR expert linguists understand both the intricacies of language and medical device terminology. To learn more about our MDR translation services please click below to learn more.
MDR Compliant Translation Services
MDR and IVDR
Language Scientific provides MDR and IVDR compliant translation services to ensure medical device companies meet stringent EU regulations by accurately translating user manuals, product labels, clinical reports and more. Our MDR translation services maintain product safety and regulatory compliance while ensuring that linguistic and cultural nuances are met. Language Scientific ensures clear communication with healthcare professionals and patients. Our MDR translation services reduce misinterpretation risks and facilitate regulatory approvals, ensuring the safe and effective use of medical device products across diverse regions.
Quality MDR Translation
Language Scientific provides high-quality translations ensure clarity, precision, and consistency, addressing specific linguistic and cultural nuances of each target market. We support regulatory compliance, enhancements to user safety, and help facilitate effective communication with healthcare professionals and patients. Ultimately, Language Scientific provide quality translations help medical device companies maintain their reputation, meet regulatory requirements, and ensure their products are safely and effectively used worldwide. Language Scientific’s Quality Management System is ISO 9001:2015 and ISO 17100:2015 certified.
Medically Accurate
Language Scientific is unique among translation services companies for a number of reasons, all of them stemming from our original mission: Language Scientific is the only major company in the translation industry founded and managed by translators with backgrounds in engineering, science and medicine, not by people whose primary experience is in languages or business.
At Language Scientific, we are driven by the mission to set the new Standard of Quality for technical translation and localization. It is this mission that drives our success and sets us apart as a company. When you need precise global communication, Language Scientific is the clear choice.
Medical Device Translation Services
Marketing your medical devices outside the country in which they were developed requires careful translation of all instructions and specifications. It can also require rebranding to account for cultural differences. Language Scientific is a leading provider of medical device translation services in the United States. We have an experienced team of medical translators and editors with impeccable linguistic skills, technical writing expertise, and most important, professional degrees such as MD and PhD, in all major areas of life sciences, biomedical engineering and medicine.
Complying With European In-Vitro Diagnostic Regulation (IVDR) Language Translation Requirments
The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate clinical trials in one of the EU countries, or when they release a product with its corresponding marketing materials into the market. With all such materials, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold.
Sample Medical Device Documents We Translate
Certificates of Analysis
Clinical Study Reports
Informed Consent Forms (ICFs)
Instruction Manuals
Marketing Materials
Packaging Inserts
Patient Information Leaflets
Product Brochures
Product Labels
Quality Documentation
Regulatory Submissions
Scientific Publications
Software and Website Localization
Technical Specifications
Training Materials
User Guides
Languages We Translate
Language Scientific provides EU MDR translation services in over 215 global languages. This broad range of languages is often important when translating medical device documentation, due to increasing globalization of the medical device industry. Nevertheless, most of our medical translation work involves translation between English and the major world languages including all languages required for EU MDR compliant translation services.
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