Medical Device Content Translation and Automation Solutions

TransPerfect Medical Device Solutions is the first supplier to combine ISO 13485, 14971, 9001, 18587, and 17100 certified, patented language services with validated process automation technologies to meet the content management and translation challenges of evolving global regulations.

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Automation Solutions for MDR & IVDR

Discover how the EnCompass system and other TransPerfect automation technologies can drive productivity and reduce costs for all types of regulated medical device content, including Instructions for Use (IFU), product labeling, Summary of Safety and Clinical Performance (SSCP), Summary of Safety Performance (SSP), user interfaces (UIs), marketing materials, Post-Market Surveillance Reports (PSMR), and more.

Translation Solutions for MDR & IVDR Compliance

TransPerfect’s translation solutions are engineered to address the stringent new requirements of the EU Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR) EU 2017/746. 

Our ISO 13485, ISO 18587-certified processes leverage AI-powered translation technologies to ensure consistent, accurate translations across all regulated content types, including Instructions for Use (IFUs), user manuals, SSCPs and SSPs, e-learning/training materials, software UI and all other medical device content.

Automation for MDR & IVDR Part 3 EnCompass Step by Step A Detailed View of the Content Automation Solution to Meet MDR & IVDR Requirements

Boost Productivity 10x, Reduce Costs by 50%, and Improve AI Performance by 60%

TransPerfect’s EnCompass solution provides dramatic cost savings and productivity boosts for all types of regulated content by automating content updates and eliminating manual formatting processes. The complete solution includes three modular components: CCMS/XML content management, translation process automation, and AI-supported translation. These components can be implemented individually or as an integrated system. The system can be licensed for maximum control or accessed through a subscription for occasional users.

Equally important, the CCMS/XML-based architecture of the EnCompass system provides the perfect training context for your corporate AI initiatives. The two most important areas of process AI development in the device industry are advanced information retrieval and content generation - both of which require the structured data that is the natural by-product of an EnCompass implementation. 

Certified System and Patented Processes

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Leading Medical Device Companies Trust TransPerfect

Top medical device organizations trust TransPerfect’s global team of 9,500+ full-time employees for content automation and flawless multilingual language services. Our team operates in 140 cities across six continents to accelerate the medical device commercialization process from lab through launch.

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Featured Resources

Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation

The global adoption of digital health solutions has revolutionized healthcare delivery, offering unprecedented opportunities for innovation in patient care, diagnostics, and disease management. However, the generation of robust clinical evidence to support these technologies across diverse regulatory, cultural, and healthcare system contexts remains a significant challenge. In this webinar, Alexandra Crane, VP of COA, Digital Health, and Regulatory Solutions at...
Clinical Evidence in Digital Health: Considerations for Multi-Country Evidence Generation

Meeting the MDR & IVDR Content Challenge: New AI and Automation Solutions for New Requirements

The European Union's introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marks a significant shift towards enhanced transparency in the medical device sector. While these regulations are designed to strengthen patient safety ...

Xtalks Webinar: Artificial Intelligence and Structured Data: Driving Process Efficiency for Medical Device Manufacturers

As more and more clinical trials are conducted internationally, with a higher level of protocol complexity, and with increased competition to get medical products to market faster globally, the need for efficient and streamlined clinical product development is greater than ever. ...

Content Solutions for MDR & IVDR Readiness

The implementation dates for MDR (May, 2021) and IVDR (May, 2022) are fast approaching and non-compliant manufacturers are putting their EU market access at risk. These new regulatory requirements have created a “tsunami” of increased content requirements—especially in critical ...

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Ensure Compliance with MDR and IVDR Standards

Discover how our solutions streamline MDR and IVDR compliance, helping life sciences companies navigate regulatory complexities with ease and accuracy.

Learn how to automate your content for compliance.

We enable medical device companies to reach new markets globally by connecting with their audiences and providing the best possible customer experience—in any language. Talk to a local content automation expert today.

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