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.

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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. 

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Certified System and Patented Processes

View and download our certifications

Translate Your Medical Device Content

For over 30 years, TransPerfect Medical Device Solutions has been exclusively devoted to medical device content translation and automation. We were the first translation service to register to ISO 13485 and the first company in the world to register to ISO 14971. We hold the only patent for medical device labeling translation. 

TransPerfect is also the only company to test our translators in 12 different medical device subject matters (e.g. imaging, orthopedics, and dental) and two medical device content types (labeling, marketing). Our experience and specialization guarantees that your IFUs, SSCPs, software, e-learning and other multilingual content will meet the increasing requirements of MDR, IVDR, and other global regulations. 

Discuss Your Translation Needs with Our Experts

Regulatory and Compliance Translation
  • Instructions for Use (IFU)
  • Summary of Safety and Clinical Performance (SSCP)
  • Summary of Safety and Performance (SSP)
  • User Manuals and Guides
  • Patient Information Leaflets (PILs)
  • Medical Device Reporting (MDR) and Regulation Documents
  • In Vitro Diagnostic Regulation (IVDR) Documents
  • Safety Data Sheets (SDSs)
  • Periodic Safety Update Report (PSURs)
  • Device Labeling and Packaging
  • Regulatory Submissions (e.g., CE Marking, FDA 510(k) submissions)
  • Declarations of Conformity (DoC)
  • Adverse Event (AE) and Serious Adverse Event (SAE) Reports
  • Technical Files and Product Specifications
  • ISO 13485 Documentation
  • Risk Management Reports
  • Patient Implant Cards
  • Medical Device Vigilance Communications
  • Patient Recruitment Communications
  • Regulatory Affairs and Compliance Content

Clinical Trial and R&D Translation
  • Clinical Study Protocols
  • Informed Consent Forms (ICFs)
  • Investigator Brochures (IBs)
  • Case Report Forms (CRFs)
  • Clinical Evaluation Reports (CERs)
  • Serious Adverse Event (SAE) Reports
  • Clinical Data Submission Documents
  • Post-Market Surveillance (PMS) Documents
  • Clinical Study Agreements (CSAs)
  • Clinical Trial Authorizations (CTAs)
  • Clinical Trial Applications
  • Premarket Approval (PMA) Materials
  • Clinical Study Reports (CSRs) 

Manufacturing and Quality Assurance Translation
  • Manufacturing Process Documentation
  • Technical Writing
  • Technical Publications
  • Standard Operating Procedures (SOPs)
  • Quality Control (QC) and Assurance (QA) Reports
  • Test Reports and Validation Documents
  • Audit and Inspection Reports

Marketing and Product Communication Translation
  • Website Content
  • Digital Marketing
  • Marketing Brochures, Flyers, Emails
  • Marketing Communications
  • Product Datasheets
  • Blogs, White Papers, Ebooks, and Other Content Assets
  • Digital and Social Media Content
  • User Testimonials and Reviews
  • Press Releases and News
  • Investor Relations Materials
  • Events, Conferences, Summits
  • Sales Collateral and Multimedia
  • Case Studies

New Product Development, Software, and Digital Health Document Translation
  • Software User Interfaces (UIs)
  • Device, App and Wearables Graphic User Interfaces (GUIs)
  • Software as a Medical Device (SaMD) Documentation
  • Mobile Application Content
  • Combination Medical Device Content
  • E-Learning Modules and Training Materials

Training and Educational Material Translation
  • Training Manuals
  • Patient Training and Education
  • Healthcare Provider (HCP) Training
  • Surgical Techniques
  • E-Learning Programs
  • Video Tutorials
  • Internal Staff Training Documentation

Legal and Financial Document Translation
  • Licensing Agreements
  • Patents and Intellectual Property
  • Supplier Contracts and Agreements
  • Insurance Documents
  • Financial Reports

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

AI in Clinical and Regulatory Content: Trends, Challenges, and Opportunities

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During this webinar, we will unveil the results of our industry survey on the role of Artificial Intelligence (AI) in clinical and regulatory content. This session will explore how AI is being evaluated and applied to search, analyze, and generate clinical and regulatory content, offering valuable insights into emerging trends, key challenges, and future opportunities. AI is increasingly being utilized in medical device products… but what about medical device processes...
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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 ...
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Xtalks Webinar: Artificial Intelligence and Structured Data: Driving Process Efficiency for Medical Device Manufacturers

Since the advent of artificial intelligence (AI), medical device manufacturers have been early adopters for product enhancements. Now, manufacturers are evaluating their regulated content and other production processes for suitable applications of AI and automation technology. ...
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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.

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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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