In the medical device field, an inaccurate translation is more than a typo, it’s a patient safety risk, a regulatory roadblock, and a significant legal liability. At Language Scientific, we solve the colossal need for certified, medical-grade accuracy that keeps your company out of the news and your devices on the market.
In the medical device industry, inaccurate translation has severe consequences, including patient safety risks, regulatory delays, and significant legal liability. Generic machine translations fall short because they lack the technical contextual understanding and specific terminology required for complex devices. We provide the precision and regulatory understanding necessary to avoid the high costs of AI-translation errors.
● The Scientist-to-Scientist Advantage: We don’t just hire linguists; we hire peers who speak your technical language. Every project is handled by a dual-review team featuring certified linguists and a Subject Matter Expert (SME) with an advanced degree in engineering, medicine, or science. This is critical because you simply cannot translate what you do not understand.
● The “LS Certified” Stamp: Language Scientific provides formal certification required to confirm medical-grade accuracy and compliance with national and international standards including MDR and IVDR.
● Fit-for-Purpose AI Workflows: We meet you where your specific translation needs are, offering workflows that range from fully manual to AI-optimized, human-verified processes. We leverage AI to drive efficiency while ensuring every word is verified by expert human eyes to maintain 100% regulatory compliance.
We specialize in the complex documentation that keeps your global operations running and compliant:
● MDR & IVDR Compliance: Expert translation for EU Declaration of Conformity, technical files, and Field Safety Notices (FSNs).
● Technical Documentation (IFUs & Manuals): Precision translation of Instructions for Use (IFUs), service manuals, and package inserts where technical accuracy is non-negotiable.
● Software & UI Localization: Seamless adaptation of software interfaces and eLearning modules for global users, ensuring consistency across all digital touchpoints.
● Regulatory Submissions: Accurate, timely translations for FDA, EMA, and other international governing bodies to ensure your go-to-market dates are met.
We prioritize the metrics that matter to Procurement and Regulatory Managers:
● 99.7% On-Time Delivery Guarantee: We understand that your clinical and launch timelines are absolute. We guarantee on-time delivery for every project we work on.
● Full Transparency Portal: Access our client portal for real-time progress tracking and proactive issue resolution. Everything is documented for your internal audits.
● Industry-Leading Certifications: Our workflows and quality management systems are ISO 17100, ISO 9001, and ISO 27001 certified, providing 100% regulatory compliance and risk mitigation.
● Data Security: We protect your patient and proprietary data with HIPAA and GDPR-compliant protocols.
From In-Vitro Diagnostics (IVD) to surgical robotics, we provide the language and technical expertise your device demands.
Accurate translation ensures regulatory compliance, patient safety, and proper device usage. Errors in translation can lead to misuse, safety risks, and regulatory rejections by agencies like the FDA, EMA, and MDR authorities.
Medical device translations cover a wide range of materials, including:
We use AI-optimized workflows combined with subject-matter expert linguists, rigorous quality control, and back translation when required. Our process follows ISO 17100:2015 and ISO 9001:2015 standards for medical translations.
Yes! We specialize in medical device software localization, including user interface (UI), eLearning modules, and multilingual voiceovers. We ensure translated content aligns with technical requirements and regulatory standards.
Turnaround time depends on document complexity, language pairs, and regulatory requirements. However, our AI-optimized translation process ensures fast, high-quality results without compromising accuracy.
Yes! We provide multilingual translation services for over 215 languages, ensuring global market access while maintaining technical precision and compliance.
Back translation is the process of translating a document back into its original language to verify accuracy. It is often required for regulatory approval and quality assurance in medical device documentation.
Yes! We provide certified translations with Certificates of Translation Accuracy (COTA) to meet regulatory requirements for medical device approvals.
We follow strict data security protocols, including NDAs, GDPR compliance, HIPAA regulations, and secure file transfers, ensuring full confidentiality of sensitive medical device information. Our technology management system is ISO 27001 certified.
Language Scientific offers expedited services for urgent projects while maintaining our commitment to quality and accuracy. We work with you to meet tight clinical trial deadlines.
Stop settling for generalist translation. Get the technical precision and regulatory certainty of the only provider led by scientists and engineers.
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