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.
At Language Scientific, we specialize in providing precise and culturally sensitive translations for the in-vitro diagnostic (IVD) industry, ensuring compliance with international regulations and effective global communication.
Regulatory Compliance: We deliver translations that meet the stringent requirements of the European Union’s In-Vitro Diagnostic Regulation (IVDR), facilitating smooth market entry and adherence to local laws.
Expert Linguists: Our team comprises professionals with deep expertise in medical device terminology and language intricacies, ensuring accurate and contextually appropriate translations.
Quality Assurance: Our ISO 9001:2015 and ISO 17100:2015 certified quality management system guarantees high-quality translations that address specific linguistic and cultural nuances of each target market.
Comprehensive Document Support: We handle a wide range of IVD-related documents, including user manuals, product labels, clinical reports, and regulatory submissions, ensuring all materials are accurately translated and culturally adapted.
Ensuring compliance with the European Union’s In-Vitro Diagnostic Regulation (IVDR) is crucial for medical device companies operating within EU markets. A key component of this compliance involves adhering to specific language translation requirements.
Mandatory Translations: All information accompanying in-vitro diagnostic devices, including labeling instructions and Instructions for Use (IFUs), must be translated into the official EU languages of the countries where the device is marketed.
EU Declaration of Conformity: This declaration must be translated into the official languages required by each EU member state where the device is available.
Field Corrective Actions: Documentation related to corrective actions must be translated into the official languages of the countries where the device is distributed.
Importance of Compliance:
Patient Safety: Providing clear and accurate information in the local language ensures proper device usage and enhances patient safety.
Regulatory Approval: Meeting language requirements is a critical step in obtaining and maintaining market access within the EU.
Ensuring compliance with the European Union’s Medical Device Regulation (MDR) is essential for medical device companies aiming to market their products within EU member states. A critical aspect of this compliance involves adhering to specific language translation requirements.
Mandatory Translations: All information accompanying medical devices—including labels, instructions for use (IFUs), and marketing materials—must be translated into the official languages of each EU member state where the device is marketed.
Regulatory Documentation: Documents such as the EU Declaration of Conformity and technical files must be available in the required languages of the respective countries to facilitate regulatory reviews and approvals.
Patient Safety Information: Critical safety information and clinical data intended for patients and healthcare professionals must be accurately translated to ensure proper understanding and usage of the medical device.
Importance of Compliance:
Regulatory Approval: Meeting language obligations is a prerequisite for obtaining and maintaining market access within the EU.
Patient Safety: Providing clear and accurate information in the local language ensures proper device usage, thereby enhancing patient safety and reducing the risk of errors.
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.
Medical materials translated by doctors, edited by linguists
No PM fees or hidden fees, complete pricing transparency
99.7% of projects completed by promised deadline
Linguists are tested and accredited by language pair and subject matter expertise
Project Manager response time < 2 hours
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.
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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