Expert Medical Device Translation Services for Global Market Access
Achieve Seamless Regulatory Compliance and Connect with Global Patients Through ISO-Certified MDR & IVDR Translation Solutions
ABOUT US
Precision Medical Device Translation for Global Compliance and Patient Safety
For over 27 years, our specialized medical translation division has delivered professional linguistic evaluation to numerous world-leading medical device manufacturers. EC Innovations’ advanced technology and global research capabilities, built over more than a century, continuously drive the development of new data-driven solutions and digitalization capabilities.
Our medical device translation services are delivered through a highly transparent methodology, enabling us to address professional standards such as MOI and PID across all major life sciences domains. For the translation profession, we integrate industry-specific management and communication systems with various external suppliers and contractors, ensuring translations are accurate, consistent, and technically precise.
Translation Accuracy Is Our Number One Priority
EC Innovations is one of only a few translation vendors in the world to receive ISO 13485:2016, ISO 9001:2015 and ISO 17100:2015 certifications. For more than 27 years, our medical translation department has provided professional language solutions to many world-leading medical device manufacturers. EC Innovations facilitates your global outreach in more than 130 languages, building the necessary trust to preserve long-term client relationships. Read our clients’ testimonials here.
EC Innovations’ medical device translation services are provided by a highly-trained team of medical translators and editors with professional degrees such as MD and PhD, in all major areas of the life sciences. For the translation processes, we integrate terminology management and computer-assisted translation solutions with our team of subject matter experts, to ensure that translations are accurate, consistent, and technically correct.
Technology Solutions
TBMS
Manages workflows, cuts project management time, reduces costs, and improves efficiency.
Cloud CAT
Cloud-based CAT tool, centralizes our global translation workforce on one platform.
ECI Connector
Connect your global-ready CMS to our translation environment, highly experienced team, and all of our translation resources.
AI-Powered Medical Device Translation for Precision and Compliance
EC Innovations integrates advanced AI with deep regulatory expertise to deliver accurate, consistent, and efficient medical device translations. Our proprietary platforms—ECI Link and EC Flow—streamline workflows, manage complex terminology, and ensure strict adherence to MDR and IVDR requirements.
With AI-enhanced tools like TBMS Cloud, smart CAT connectors, and the ECI Connector, we maintain terminology consistency across all documents—from technical files to patient materials. This combination of technology and expertise enables scalable, secure, and compliant solutions for global market success.
- Medical Device Software Localization
- Medical Device Registration and Application Solutions
- IP and Legal Services
- Digital Marketing Content Solutions
COMPREHENSIVE MEDICAL DEVICE TRANSLATION SERVICES
Medical Device Software Localization
Today, it is mostly a given fact that medical devices come with embedded software to make configuration user-friendly and facilitate the overall use of the application. Translation consistency between what appears on the software interface and user documentation is crucial, EC Innovations has developed tried and true processes for medical device GUI translation, linguistic and cosmetic testing, and internationalization, to ensure a seamless and connected experience for doctors, clinicians, and patients.
Medical Device Registration and Application Solutions
To market medical devices and their accessories in foreign markets, medical device manufacturers need to remain compliant with international and local regulatory guidelines, security specifications, or quality management in each country.
Medical translation requires precision and up-to-date technical knowledge by every member of the translation team. It also requires multiple levels of quality control, and a full understanding of stringent regulatory laws. Whether translating patient education materials or patient questionnaires, there can be no compromise of language accuracy or quality. ECI technology provides multiple ways to audit localization efforts by keeping track of changes throughout the relationship with the client, controlling versioning history, and managing user’s permissions.
IP and Legal Services
For patent innovations in medical devices, the importance of patent translation to obtain legal recognition of your intellectual property when your business takes you from one market to another cannot be overstated. EC Innovations understands that accuracy and subject-matter expertise are critical, especially when millions of dollars in intellectual assets, important research, and business decisions are at stake.
EC Innovations stays on top on the industry with up-to-date information on national patent office rules, and the delivery lifecycle that is associated with the foreign prosecution process, having collaborated with industry-leading patent departments for over 20 years. Together with our highly trained patent translators, experienced technical field expertise, and an ISO certified QA process; EC Innovations can assist you throughout the entire process.
Being aware of the importance of confidentiality in the IP industry, we are fully committed to ensuring the safety, confidentiality, and integrity of your documents and any information communicated to us.
Digital Marketing Content Solutions
EC Innovations’ optimal support with our premium services for Translation, localization, and media adaption of marketing materials and websites ensures that your message is always perfectly in tune with your target group. Our localization processes are specifically geared toward the requirements of the medical devices industry, our well-trained linguists and tested methodologies ensure your valuable stories are as well-crafted and impactful as the source language ones, and strategically transform them through creative execution.
EC Innovations has a dedicated multimedia and e-learning group that teams up with you to guarantee your globally dispersed workforce meets your standards. We offer end-to-end solutions for localizing videos, Training Courses, apps, etc. with services that include multilingual voiceover, desktop publishing, subtitling, video editing, and audio engineering.
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Ensure Global Market Access with Expert Medical Device Translation
Quality Assurance Specific to Medical Device Translation
Our quality assurance process is meticulously designed for medical device documentation, combining rigorous linguistic validation with regulatory compliance checks. Each translation undergoes multiple layers of review by subject-matter experts and native linguists specializing in medical terminology. We employ advanced terminology management systems to ensure consistency across all project phases and documents, from technical specifications to patient-facing materials.
Medical Device Document Translations
We specialize in translating the full spectrum of medical device documentation with precision and regulatory awareness. Our services cover:
Technical Files & Design Dossiers
- Complete translation of technical specifications, engineering documents, and design history files.
Instructions for Use (IFUs) & User Manuals
- Patient-friendly translations that meet readability requirements and safety standards.
Labeling & Packaging
- Accurate translation of all label content, including symbols, warnings, and usage instructions.
Clinical Evaluation Reports (CERs) & PMCF
- Translation of clinical data and post-market surveillance documentation.
Regulatory Submission Documents
- Preparation of translated documents for FDA, CE Marking, NMPA, and other global regulatory bodies.
Quality Management System (QMS) Documentation
- Translation of SOPs, validation protocols, and audit reports.
Marketing Materials & Training Content
- Culturally adapted translation of product brochures, sales materials, and training programs.
MDR & IVDR Translation Compliance
Our medical device translation services are specifically engineered to meet the stringent requirements of the EU Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR) EU 2017/746. We ensure that your translated technical documentation, including Instructions for Use (IFUs), Summary of Safety and Clinical Performance (SSCP), and product labels, strictly adheres to the latest regulatory standards and notified body expectations. Our ISO 13485 and ISO 17100-certified processes provide a robust framework for quality and compliance, giving you confidence in your global submissions.
EC Innovations Advantage
EC Innovations Life Sciences has been an established leader in medical device translation for over 27 years. What sets us apart from the rest?
Qualifications and Standard Compliance
EC Innovations Life Sciences holds ISO 13485:2016 and ISO 17100:2015 certification for the translation and localization of the accompanying content for biotech and medical devices.
EC Innovations Life Sciences complies with high quality standards of the life sciences sector to meet end user’s expectations and patient safety. We are especially honored to be Siemens’ Outstanding Language Service Provider since 2007.
Dedicated Life Sciences Division
With focus and commitment comes professionalism, EC Innovations Life Sciences is a division with more than 100 employees dedicated to serving only the life sciences industry.
Innovative technologies (TBMS LPA) make continuous delivery possible
We’ve been continuously refining our TBMS LPA system more than 15 years ago to fit the business trends and compliance needs of our medical device clients. Our proprietary technology enables the workflow automation for content transfer, file preparation, instant quotation, maintenance of language assets, KPI evaluation, data mining for decision making, translation quality report generation, among others. This allows us to shorten turnaround time and lower cost without compromising quality, and make continuous delivery an achievable solution. Refer to TBMS LPA for more information.
Project Team as the Cornerstone of Quality
Our translation team mainly comprises native speakers of the target language who take on the following roles:
- Subject-matter experts (SME): Possessing medical background with cumulative experience and knowledge in medical translation, our SMEs support terminology translation and maintenance as well as answer technical questions from translators.
- Qualified translators: Our translators undergo assessment based on our Translation Quality Report (TQR), and we try our best to assign translators to the same product line for the same client.
- Experienced editors: With years of experience in medical device translation, our editors are effective at using our cloud-based Computer-assisted Translation tool to review and make edits in real time to provide feedback and confirmation in the shortest time possible.
- Rigorous proofreaders: Equipped with background knowledge of related medical devices, they simulate end users by reviewing the translation with a fresh eye and without referencing source content.
- Quality Assurance reviewer: Our QA team will sample 10% to 20% of total translations to independently verify quality and identify potential quality issues.
- In-country reviewers or third-party reviewers: Often requested by clients to serve as a further guarantee of translation quality.
- In-country language leader: Work closely with our translator recruitment and management team to build tailored and dedicated translator teams for each client.
- Multilingual DTP team: Ensure that translated documents are compliant and ready to be published in the right format.
Strengths
Why Choose Our Medical Device Translation Services
EC Innovations vs. Typical Localization Providers
| Comparison Criteria | EC Innovations Advantages | Typical Provider Limitations |
|---|---|---|
| Regulatory Expertise | ✅ Dedicated subject-matter experts with deep understanding of MDR/IVDR requirements and notified body expectations. | ❌ Use generalist translators lacking specific medical device regulatory knowledge. |
| Quality & Certification | ✅ Dual ISO 13485 & ISO 17100 certification ensures a quality management system specifically designed for medical device compliance. | ❌ May hold ISO 17100 but lack the critical ISO 13485 for medical devices. |
| Technology & Security | ✅ Secure ECI Link client portal and advanced terminology management (TBMS Cloud) ensure consistency and data security. | ❌ Rely on email and unsecured file-sharing methods, risking data breaches. |
| Linguistic Assets | ✅ Develop device-specific terminology glossaries upfront to ensure consistency across all project phases and documents. | ❌ Reuse vague or inconsistent terms from translation memories, leading to errors. |
Subject Matter Experts and Translation Teams in Medical Devices
Our linguists are not just translators; they are specialized experts with advanced degrees in life sciences, medicine, or engineering, coupled with years of experience translating for the medical device industry. This dual expertise ensures that your projects are handled with the precision and regulatory understanding they demand.
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, ISO 27001, and ISO 14001 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 27001
ISO 14001
Essential Insights for Medical Device Globalization
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…
Medical Terminology Translation: Key Challenges and Expert Solutions
A single mistranslated word can mean the difference between life and death. Which means medical…
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…
Get in touch
Ensure your medical devices achieve global compliance and market success. Contact our regulatory translation specialists today for a confidential consultation and a precise quote.
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