MDR End-to-End Compliance: From Precision Translation to Global Market Access
Navigating EU MDR & IVDR requirements with certified mdr translation services and regulatory expertise for seamless market approval.
MDR Translation: Your Gateway to European Market Compliance
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) represent the most significant regulatory overhaul in decades. With 70% of MDR delays stemming from translation errors, precision in technical documentation is not just important—it’s critical for market access. Proper MDR translation ensures your device’s technical files, labeling, and clinical evidence meet stringent EU requirements, preventing costly resubmissions and accelerating your path to approval.
Pan-European Regulatory Expertise: Beyond Basic Translation
True compliance requires more than word-for-word translation—it demands deep regulatory understanding across all EU member states. Our European-based team provides localized expertise for Germany’s BfArM, France’s ANSM, and other national competent authorities. We continuously monitor regulatory updates across all jurisdictions, ensuring your submissions remain compliant even as requirements evolve, providing true future-proof medical device translation services.
Future-Proof Compliance: Staying Ahead of Evolving MDR & IVDR Requirements
Our team continuously monitors regulatory updates across all EU member states, ensuring your medical device translations remain fully compliant even as MDR and IVDR requirements evolve. We adapt swiftly to amendments, preventing delays and resubmissions—so you stay ahead in the competitive European market.
Ready to Navigate MDR/IVDR Complexity with Confidence?
AI-Powered Precision: Enhancing MDR Translation Efficiency
Our proprietary ECI Link platform integrates advanced AI translation with human expertise for unmatched mdr translation accuracy. The system maintains consistent terminology across all documents while our specialized linguists perform meticulous post-editing to ensure regulatory compliance and contextual appropriateness. This powerful combination delivers both speed and the nuanced understanding that AI alone cannot achieve.
Strengths
Why 200+ Global Brands Choose ECI for MDR Translation
EC Innovations vs. Typical Localization Providers
| Comparison Criteria | EC Innovations Advantages | Typical Provider Limitations |
|---|---|---|
| Regulatory Depth | ✅ EU-based regulatory specialists + translation experts | ❌ Separate translation and consulting services |
| Technology Integration | ✅ ECI Link platform with AI-powered terminology management | ❌ Basic translation tools without regulatory alignment |
| Update Adaptability | ✅ Proactive monitoring of MDR/IVDR amendments across EU states | ❌ Reactive approach to regulatory changes |
| Comprehensive Coverage | ✅ Full MDR/IVDR documentation suite + post-market support | ❌ Limited to basic technical documentation |
| Quality Assurance | ✅ Triple-check system: AI + linguist + regulatory expert review | ❌ Basic linguistic review only |
About EC Innovations
For 28 years, EC Innovations has been a reliable provider of top-notch translation and localization services, delivering solutions in an accurate and compliant manner, to global customers in the medical device industry. We specialize in mdr translation services that bridge the critical gap between linguistic accuracy and regulatory compliance.
Subject Matter Experts and Translation Teams in MDR & IVDR Compliance
Our specialized team includes EU regulatory affairs specialists, medical device engineers, and professional linguists who work collaboratively to deliver translations that are not only linguistically perfect but also fully compliant with the complex requirements of MDR and IVDR regulations across all European markets.
TEAMS
Subject-matter experts (SMEs)
With appropriate industry backgrounds,meet SMEs with extensive experience of document translation. They support terminology translation and maintenance while answering any technical questions translators may have.
TEAMS
Qualified translators
All our translators receive thoroughgoing assessment based on our Translation Quality Report (TQR). We also take the trouble to match translators to particular clients and product lines, to see that their knowledge of your business – and hence their utility on your projects – is always growing.
TEAMS
Experienced editors
With years of experience in document translation, EC Innovations’ editors use our cloud-based Computer-assisted Translation tool to review and make edits in real time. Generating feedback and approvals in the shortest possible time-frame.
TEAMS
Exacting proofreaders
Background knowledge in the relevant field allows our proofreaders to play the part of end users. They always review translations with a fresh eye, and without reference to source content.
TEAMS
Quality assurance reviewer
Our QA team samples 10% to 20% of total translations. Clients get independent verification of quality – and immediate identification of any issues.
TEAMS
In-country reviewers or third-party reviewers
Always available on request to serve as further guarantors of translation quality.
TEAMS
In-country language leaders
These key individuals work closely with translator recruitment and management to build dedicated teams of translators for each client.
TEAMS
Multilingual desktop publishing team
Readying translated documents for publication in the correct format, to ensure compliance.
CERTIFICATION
ISO Certified
We are one of the few language service providers in the world that holds ISO 9001, ISO 17100, ISO13485, ISO 27001, and ISO 18587 certifications.
We attach a high degree of importance to the delivery and quality assurance process of translation services. For EC Innovations, providing quality services has always been the guiding force behind our corporate values and beliefs. We do this by implementing rigorous and comprehensive quality assurance procedures, following comprehensive guidelines and checklists embedded throughout the entire project lifecycle. Tasks with substandard results will be reworked until the required quality level is achieved.
ISO 9001
ISO 17100
ISO 13485
ISO 27001
ABOUT US
Leading Pharmaceutical, Biotechnology, CRO, and Healthcare Organizations Trust Our Expertise
At EC Innovations, we specialize in delivering customized life sciences translation services at scale. Don’t just take our word for it—hear what our clients say about the impact of our expert life sciences translation services on their global projects.
How long does a typical MDR translation project take?
Depending on document complexity, most projects take 2–6 weeks. We offer expedited services for urgent submissions.
Do you provide certified MDR translations?
Yes, we deliver certified mdr translation services that meet EU and national authority requirements.
How do you handle country-specific regulatory differences?
Our EU-based specialists tailor translations to align with local authorities like BfArM (Germany) and ANSM (France).
Can you support both MDR and IVDR documentation?
Absolutely. We provide integrated mdr translation and IVDR services for full compliance coverage.
What is your quality assurance process?
We use a triple-check system: AI-powered translation, linguistic review, and regulatory expert validation.
Do you work with startups or small businesses?
Yes, we offer scalable mdr translation packages designed for startups entering the EU market.
How do you ensure terminology consistency?
Our ECI Link platform maintains AI-powered terminology databases aligned with MEDDRA and ISO 13485 standards.
Can you translate clinical evaluation reports (CERs)?
Yes, we specialize in translating CERs and other clinical documents for MDR/IVDR submissions.
What languages do you support for MDR translation?
We cover all EU official languages, including German, French, Spanish, Italian, and more.
How do I get started with my MDR translation project?
Contact us for a free consultation. We’ll assess your needs and provide a tailored project plan and quote.
Essential Guides for MDR & IVDR Translation Success
What Is ISO 13485 and Why It Matters in Medical Device Translation
Medical device companies are racing to reach international markets. The numbers tell the story: global…
How to Prepare a Clinical Evaluation Report for EU MDR Compliance
Medical device makers entering Europe face one key challenge: creating a compliant clinical evaluation report…
EU In Vitro Diagnostics Regulation (IVDR): Top 6 Questions Answered
Regulations can make or break a product’s future in Europe. The EU In Vitro Diagnostics…
Get in touch
Navigate MDR/IVDR complexity with confidence. Contact our regulatory translation specialists today for compliant, accurate translations that ensure your medical devices gain seamless access to European markets.
"*" indicates required fields