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 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 120 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

Projekto

TBMS

manages workflows, cuts project management time, reduces costs, and improves efficiency.

Cloud CAT

Cloud CAT

Cloud-based CAT tool, centralizes our global translation workforce on one platform.

CMS Connector

CMS Connector

Connect your global-ready CMS to our translation environment, highly experienced team, and all of our translation resources.

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.

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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.

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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.

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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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Quality Assurance Specific to Medical Device Translation

Clinical monitoring, treatment, and operation equipment need to be properly configured and meticulously implemented. Errors in user manual translations may lead to unsafe operations that could threaten the end user’s health, or even life. User manual translations should be verified by SMEs and linguists on issues including (but not limited to) GUI translation, terminology translation, units of measurement conversion, and so on.

Due to the highly technical and complex nature of medical device content, our team of translators, editors, proofreaders, in-country reviewers, QA reviewers, and engineers uses our cloud-based Computer-assisted Translation tool to complete the translation with effective communication and seamless collaboration.

Medical Device Document Translations

EC Innovations has experience translating all types of medical device documents, such as product manuals, labels, patents, data sheets, reports, user guides, package inserts, and marketing collateral.

Manuals and Descriptions

  • Instructions for Use
  • Operating Manuals
  • Installation Manuals

Patents and Regulatory Compliance Documents

  • Patents for Medical Devices
  • Patents for Surgical Devices
  • Medical Device Graphic User Interface
  • Regulatory Compliance Documents for US, European Union,
    and Asian countries
  • Manufacturing Process Descriptions
  • Package Inserts and Labels

Other Translation and Localization Services

  • Website Content
  • Advertising and Marketing Materials
  • Training, Educational Documents, and Multimedia Materials

The EC Innovations Difference

EC Innovations Life Sciences has been an established leader in medical device translation for over 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.

ISO-Certified Quality Assurance

Just like the clients we serve, we pay the utmost attention to the delivery and quality assurance processes of our products and services. EC Innovations Life Sciences complies with the highest quality standards of the life sciences industry to meet the end user’s expectations and patient safety.

EC Innovations Life Sciences holds ISO 13485:2016 and ISO 17100:2015 certification for the translation and localization of the accompanying documentation for medical devices.

ISO 13485 certification is awarded to companies that have successfully implemented a quality management system that meets the medical device industry’s regulatory requirements, with a focus on risk management and strict quality control. The ISO 17100 standard specifies requirements for all aspects of the translation process, directly affecting the quality and delivery of translation services.

For ECI, offering high-quality services has always been the guiding force behind our company values and beliefs. Seeing this through entails a strict and extensive Quality Assurance procedure, based on comprehensive guidelines and checklists embedded into the entire life cycle of a project. If the outcome of a task does not satisfy the criteria, the task is reworked until the required level of quality is attained.

Nevertheless, we are perfectly aware that our work is judged not only by the quality of the end product, but also by the effectiveness of our communication, the professionalism of our presentation, our interaction with customers, and our ability to work within the client’s budget.

Our cloud-based Computer-assisted Translation tool can automatically generate a Translation Quality Report and quality score for each project and can quantitatively evaluate translation quality and translator performance. The quality score is valuable in order for translator team optimization to improve translation quality in the long run, especially for teams that work on projects of the same nature for an extended period of time.

iso 17100
(Click to download certificate)
iso 13485

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