Medical Device Translation Services
Medical device translation gets complicated fast because the content is regulated, the terminology is technical, and the consequences of ambiguity are real. Language Scientific provides specialized translation services for medical device companies operating in highly regulated global markets. That focus shapes everything from linguist selection to workflow design, so teams can translate at scale without losing control of meaning, formatting, or version history.
To keep technical intent intact, all translations are completed by subject-matter expert linguists with backgrounds in medical devices, engineering, and life sciences. This matters most when content spans multiple audiences—regulators, clinicians, service teams, and patients—where the same concept must remain consistent across IFUs, labeling, software UI, and supporting documentation.
Regulatory-First Workflows, Built for Submissions
Translation is not just a language step; it is part of your compliance process. Translation workflows are designed to support regulatory compliance with FDA, EU MDR, and other international medical device regulations. That includes terminology discipline, structured review stages, and documentation practices that help teams stay aligned to controlled source files and approved target-language phrasing.
Speed is often required, but not at the expense of control. The translation process is designed to meet tight regulatory timelines and support on-time submissions and product launches. The goal is to reduce review cycles and prevent avoidable rework by flagging issues early, keeping cross-document consistency, and delivering files in formats that fit your document control system.
AI-Optimized Translation, Guided by Human Expertise
Large device programs often involve repeated language across multiple documents and multiple versions. That is where technology helps most. AI-optimized translation technology is combined with expert human review to improve consistency, speed, and scalability across large document sets. The technology supports consistency checks and reuse across related files, while expert reviewers handle nuance, risk-sensitive wording, and the final clarity of user-facing instructions.
This approach is especially useful when multiple stakeholders review different parts of the same documentation package. Clear handoffs and defined review points help ensure the final language reflects the intended device use, not just a literal rendering of the source text.
Full Lifecycle Support Across Device Programs
Translation needs change across development, submission, and post-market maintenance. The team supports the full medical device lifecycle, from early development through regulatory submission and post-market activities. Early phases may require translation for design documentation, internal training, or usability-related materials. Submission phases typically expand into full labeling and documentation packages. Post-market work often centers on change control, updates, and safety communications that must remain aligned across languages.
Device portfolios also vary widely in risk and complexity. Language Scientific has experience supporting Class I, II, and III medical device manufacturers across a wide range of device types. That breadth helps when a single program spans hardware documentation, software prompts, clinical support materials, and quality system content that must all read consistently.
What Gets Translated and Why It Matters
Content scope is broader than many teams expect once audits, market expansion, or product updates hit. Language Scientific translates critical medical device content, including IFUs, labeling, technical files, clinical documentation, and quality system materials. That coverage helps keep the story consistent across what regulators review, what users follow, and what internal teams rely on to maintain compliance.
Just as important is how the writing lands with real users. Translations are written with patient safety and end-user clarity in mind to reduce risk and support proper device use. Clear target-language instructions help prevent misuse, reduce support burden, and keep safety messaging consistent across channels.
Global Delivery Without Losing Control
International launches require language breadth, but also discipline around variants, terminology, and updates. Multilingual translation services are available in more than 215 languages to support global product launches and market expansion. This is most effective when language planning is connected to your release process, so updates to core content propagate cleanly across every required language.
Quality, Traceability, and Data Protection
For regulated content, quality is inseparable from traceability and security. All projects follow ISO-certified quality management and information security processes to ensure accuracy, traceability, and data protection. That foundation supports consistent review practices, auditable workflows, and controlled handling of files that may contain sensitive technical, clinical, or product information.
End-to-End Support that Simplifies Management
Translation becomes easier to manage when one team can carry it from intake to final delivery, including formats and packaging that match your internal workflows. End-to-end project support is provided, from source file preparation through final multilingual delivery, to simplify translation management for medical device companies. That includes coordinating terminology inputs, aligning versions, structuring review cycles, and delivering files in submission-ready formats that reduce downstream formatting and QA friction.
Read More
Navigate global regulatory demands with our AI-optimized, on-time translation services. With IVDR and MDR expertise, we ensure accurate, compliant medical device translation services that bring your devices to market confidently.
Medical Device Translation Experience
In-Vitro Diagnostics
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.
IVDR Translation
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.
MDR
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.
Software Localization
At Language Scientific, we provide expert software localization and internationalization services to help your software, websites, and web applications resonate globally.
- UI Localization: Translating, adapting, and resizing software interfaces for seamless user experiences.
- Help & Documentation: Localizing help files and manuals with consistent, accurate translations.
- Testing: Conducting functional and linguistic tests to ensure accuracy and usability.
- Internationalization Support: Guiding your team on best practices for global readiness.
What Makes Us Different: Medical Expertise
- Expertise in global IVDR and MDR requirements to ensure compliance in international markets.
- Specialized translators with deep knowledge of medical device technology and industry standards.
- Seamless support for product launches and market entry in diverse regions.
- Commitment to quality, accuracy, and cultural adaptation for global user engagement.
- Ultimately, Language Scientific stands out from competition because of the following five reasons below.
The Language Scientific Difference
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
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.
Medical Device Translation Sample Projects
- Adverse Event Reports (SAEs)
- Batch Records and Manufacturing Batch Records
- Case Report Forms (CRFs)
- Clinical Study Reports (CSRs)
- Compliance Documentation
- Declaration of Conformity
- Device Labeling and Package Inserts
- eLearning Modules for Device Training
- Electronic Instructions for Use (eIFUs)
- Field Safety Notices
- Good Manufacturing Practice (GMP) Documentation
- Health and Safety Manuals
- Informed Consent Forms (ICFs)
- Instructions for Use (IFUs)
- Investigator Brochures
- Marketing Collateral and Promotional Materials
- Medical Device Regulatory Submissions
- Multimedia Training Videos
- Operator’s Manuals
- Patient Education Materials (CMI and PHI)
- Patient Questionnaires
- Post-Market Surveillance Reports
- Product Specifications and Datasheets
- Quality Management System Documentation
- Regulatory Filings for FDA, EMA and Others
- Risk Assessment Reports
- Sales Training Materials
- Service and Maintenance Manuals
- Site Operations Manuals
- Software and User Interface (UI) Localization
- Standard Operating Procedures (SOPs)
- Technical Datasheets
- Training Manuals
- Validation Reports
Medical Device Translation FAQs
Why is accurate translation important for medical device materials?
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.
What types of medical device documents need translation?
Medical device translations cover a wide range of materials, including:
- Instructions for Use (IFUs)
- Device labeling and packaging inserts
- Regulatory submissions (FDA, EMA, MDR)
- Clinical trial documentation
- Patient education materials
- Software UI and user manuals
Please see above for more sample medical device materials we translate.
How do you ensure translation accuracy for medical device content?
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.
Do you offer translation services for medical device software and user interfaces?
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.
How long does it take to translate medical device documents?
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.
Can you translate medical device materials into multiple languages?
Yes! We provide multilingual translation services for over 215 languages, ensuring global market access while maintaining technical precision and compliance.
What is back translation, and is it necessary for medical device translations?
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.
Do you offer certified medical device translations?
Yes! We provide certified translations with Certificates of Translation Accuracy (COTA) to meet regulatory requirements for medical device approvals.
How do you handle confidential medical device information?
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.
Can you handle rush projects?
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.
