Language Scientific provides MDR and IVDR compliant translation services to ensure IVD companies meet stringent EU regulations by accurately translating user manuals, product labels, clinical reports and more. Our IVDR 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 IVDR translation services reduce misinterpretation risks and facilitate regulatory approvals, ensuring the safe and effective use of IVD products across diverse regions.
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 IVD 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.
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.
Marketing your Invitro Diagnostic (IVD) 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.
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.
AI is redefining IVD translation by ensuring accuracy, speed and regulatory compliance across your medical devices. Our AI-optimized translation solutions streamline the translation of complex medical documentation, enabling clear communication across the globe. By combining AI efficiency with expert human review, Medical Device companies can deliver precise, reliable translations that meet the highest regulatory standards.
Language Scientific, Inc.® is a privately held corporation headquartered in Medford, Massachusetts.
Language Scientific, 101 Station Landing, Suite 500, Medford, MA 02155
+1 617-621-0940
info@languagescientific.com
