Professional and highly qualified translation services are essential when medical device manufacturers market to new countries. Translation errors can lead to additional costs, damage to reputation, lost business opportunities, delay in time-to-market, or in the worst-case scenario, lawsuits. You need a reliable language service partner to handle localization challenges and support you in winning global markets.

EC Innovations has been working with many leading companies in the biotech and medical device industries for over years.

Read our clients’ testimonials here »

Complete Translation Solutions for Medical Devices

Our localization services cover the entire spectrum of document translation, desktop publishing, software and website, e-learning, and multimedia localization:

  • Biotech and Medical Device Graphic User Interface (GUI)
  • Website Content
  • IFU (Instructions for Use)
  • Operating and Installation Manuals
  • Instructions for Care, Cleaning, Maintenance and Sterilization
  • Product Monographs and Descriptions
  • Surgical Techniques
  • Informed Consent Forms
  • Validation Reports
  • Clinical Examination Reports
  • 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.

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 work on the translation with effective communication and seamless collaboration.

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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