As medical technology continues to advance, medical institutions worldwide are increasingly using cutting-edge medical devices to treat various diseases. However, the translation of medical device documents faces multiple risks such as technical errors, cultural differences, and cross-border differences in laws and regulations. To overcome these obstacles, EC Innovations follows ISO quality processes and has introduced our own medical quality assurance measures based on ISO 13485 and ISO 17100 to meet the strict international regulatory requirements for medical device translation and language services.
For over 20 years, our medical device translation department has been providing professional and precise language solutions to many of the world’s leading medical device manufacturers.
Medical Device Document Translation Services
EC Innovations has extensive experience translating medical device documents of various types, including product manuals, labels, patents, data sheets, reports, user guides, package inserts, and brochures.
Manuals and Instructions
- Instructions for Use
- Operation Manual
- Installation Manual
Patent and Compliance Documentation
- Medical Device Patent
- Surgical Device Patent
- Medical Device Graphical User Interface
- Compliance Documents for the US, EU and Asian Countries
- Manufacturing Process Description
- Package Inserts and Labels
Other translation and localization services
- Website Content
- Advertising and Promotional Materials
- Training, Educational Literature and Multimedia Materials
High-Quality Translations by Professional Medical Device Translation Team
EC Innovations’ Life Sciences Localization division is a business unit comprising more than 100 employees dedicated to the life sciences industry.
Our translation team consists primarily of native speakers of the target language, who serve in the following roles:
Subject matter experts (SME)
With a background in the field of life sciences and a wealth of experience and knowledge in medical device translation, SMEs provide support for terminology translation and maintenance, and answer questions raised by translators.
Outstanding translators
Identified through rigorous rating based on the Translation Quality Report (TQR), the same translators are assigned to the best of our ability, for projects on the same product line and for the same client.
Experienced proofreaders
With many years of experience in medical device translation, our proofreaders are able to efficiently use cloud-based computer-assisted translation tools for real-time review and proofreading, providing feedback to translators in the shortest possible time.
Stringent reviewers
Reviewers have background knowledge of relevant clinical trials, and they examine the translations through the eyes of the end-user, without referring to the content of the source document.
Quality assurance (QA) reviewers
The QA team samples 10% to 20% of the translations for individual quality review to identify possible quality issues.
Native reviewers or third-party reviewers
Upon request by the client, native-speaking or third-party reviewers will be brought in to further ensure translation quality.
Native language leads
Native language leads work closely with translator recruitment and project managers to assemble a custom professional translation team for each client.
Multilingual desktop publishing team
This team ensures that translated documents are compliant and can be published in the correct format.
ISO certification
We attach a high degree of importance to the delivery and quality assurance processes of our products and services, and we share the same dedication to quality as our clients. EC Innovations’ Life Sciences team adheres to the highest quality standards in the life sciences and strives to meet end-user expectations and ensure patient safety. EC Innovations’ Life Science team has been certified for ISO 13485:2016 and ISO 17100:2015 medical device industry ancillary document translation and localization.
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.
Information Security
We are deeply aware of the importance of confidentiality and do our utmost to ensure the security, confidentiality, and integrity of customer documents and communications.
- Project documents are protected by adhering to strict procedures and guidelines throughout the project process.
- All project personnel are required to sign a non-disclosure agreement.
- We have passed all customer security audits, including global audits by multinational corporations.
- We have achieved ISO 27001 information security management system certification.
- Multiple data encryption technologies are adopted when transmitting data.
- Reliable backup, disaster recovery, and data recovery mechanisms in place.
We appreciate your interest in EC Innovations.
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