Fast, Accurate Medical Device Translations: Built for MDR & IVDR Compliance
Navigate global regulatory demands with our AI-optimized, on-time translation services. With IVDR and MDR expertise, we ensure precise, compliant medical device translation services that bring your devices to market confidently.
When Medical Device Translation Fails, the Consequences Are Costly
Inaccurate translations can cause device misuse, regulatory rejection, product recalls, and even patient harm. With growing global compliance requirements like MDR and IVDR, device manufacturers can’t afford translation errors or delays. Whether you're preparing IFUs, SSCPs, UI strings, or multilingual labels, our expert-led approach ensures your content is both medically accurate and regulator-ready in every required language.
- ✔Reduce audit risk by aligning terminology with risk language
- ✔Lower CAPA exposure through preventive QA & ICR
- ✔Protect patients with unambiguous, use-safe instructions
Regulatory and Compliance
Product Labeling and Packaging
Clinical And Patient Facing
A Translation Process Built to Meet Medical Device Standards
We begin by deeply exploring your specific medical device context, whether it's an IFU for a diagnostic tool, maintenance SOP, or software UI, anticipating critical distinctions like regulatory terminology, target markets (e.g., MDR, IVDR, FDA), and translation volumes.
Your project isn’t one-size-fits-all. We craft a customized translation solution that defines language scope, delivery milestones, security protocols (e.g., GDPR/HIPAA), and review cycles aligned precisely with your compliance and commercial timelines.
Your content is translated by professionals with advanced credentials who are MDs, PhDs, biomedical engineers trained in medical device technology and fluent in translation. They’re hand-picked from our ASKnetwork™ to ensure not only linguistic precision but deep domain understanding.
We deploy AI-optimized workflows to accelerate translation throughput, particularly for highly repetitive or templated content, while ensuring the final translation is refined and validated by our domain expert translators.
Our multi-step quality control system includes in-house QA, dual-stage reviews (translation + medical QA), and ISO 9001:2015 and ISO 17100:2015 certified QMS ensuring every deliverable is compliant, accurate, and traceable.
From kickoff to final delivery, you have a single, dedicated Project Manager who knows your project inside and out. They coordinate schedules, communicate in under 2 hours, and oversee quality and regulatory milestones—boosting responsiveness and reliability.
Compliant with EU MDR & IVDR Language Requirements
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.
- ✔EU MDR 2017/745 and IVDR 2017/746
- ✔SSCP language requirements for Class III and implantable devices
- ✔EU UDI & IFU multilingual content mandates
- ✔Multilingual labeling (including electronic labels/eIFUs)
File Types & Formats
Over 215 Languages
Language Scientific is a full-service translation and localization company. We translate and localize to/from over 215 languages, and we interpret into/from over 235 languages, including all the major Northern European, Eastern European, Western European, Asian, American, African, Indian and Middle Eastern languages. If you require translation services into a language that is not listed, please contact us below.
AI-Optimized. Human-Perfected.
Speed matters, but so does precision. Our workflows combine AI efficiency with subject-matter expert linguists and ISO 9001:2015/17100:2015 certified quality management system to validate every term, risk statement, and regulator-facing phrase—so you move faster without sacrificing safety or compliance.
| Throughput | Faster quote-to-submission timelines with AI-assisted prep and Translation Memory reuse. |
| Precision | Specialist editors ensure consistent use of device-specific terminology and risk language. |
| Consistency | Terminology bases + Translation Memory keep brand and regulatory language aligned. |
| Cost Control | Optimized for updates/variants; pay less for content reuse across SKUs and markets. |
Medical Device Localization—Not Just Translation
True localization adapts your content for language, culture, and regulatory expectations. From UI string internationalization to IFUs that reflect regional practice norms, we go beyond word-for-word conversion. Our team ensures:
- ✔Translatable UI/UX design
- ✔Expandable text fields and template planning
- ✔Reuse of translation memory for faster updates
- ✔Brand and terminology consistency across all markets
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
Why Top Device Manufacturers Trust Language Scientific
- ✔99.7% on-time delivery rate
- ✔ISO 9001:2015 & ISO 17100:2015 certified QMS
- ✔Translators hold degrees in medicine, biomedical engineering, or life sciences
- ✔Full confidentiality with HIPAA and GDPR compliance
Built by Scientists, Not Just Linguists
Our competitors rely on generalist translators. We don’t. Every member of our ASKnetwork™ combines linguistic mastery with real experience in medical devices, regulatory writing, or scientific research—so your content meets regulator expectations and protects patients.
Case Study: MDR Regulatory Knowledge and Language Expertise
A leading medical device company specializing in solutions for musculoskeletal (MSK) radiology, faced a unique regulatory and linguistic challenge. They developed their own AI-driven LLM to handle translations internally but needed an experienced partner to review and certify those translations for compliance with the EU’s Medical Device Regulation (MDR).
On-Time
Accurate and compliant translations
MDR
Met stringent MDR standards
Efficient
Improved operational efficiency
Actions Taken
- ✔Reviewed and certified translations produced by their internal AI-driven system
- ✔Provided specialized linguists with deep MDR and medical device expertise
- ✔Offered flexible services tailored exclusively to review and certification, rather than insisting on conducting the initial translations
- ✔Delivered proposals, quotes, and project completion quickly and efficiently
- ✔Implemented collaborative processes for consolidated feedback and digital change tracking, while maintaining confidentiality
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.
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.
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.
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.
