Medical Device Localization: Navigating Compliance and Empowering Engagement

As medtech digital health ecosystems expand, companies face growing pressure to deliver products and information tailored to each global market. Meeting that demand requires a strategic approach to medical device translation and localization spanning translation, cultural adaptation, validation, and the design of digital content and device interfaces.

With the right strategy, technology, and services in place, localization becomes more than a compliance requirement. It drives growth, builds trust, and strengthens brand reputation through meaningful engagement with healthcare providers and patients.

Why Medical Device Localization Matters

With the introduction of new regulations such as MDR and IVDR, device makers operate under some of the strictest requirements in the world. Beyond meeting technical benchmarks, companies must ensure that content is adapted to local languages, legal requirements, and user expectations.

This extends well beyond IFUs and packaging to mobile app interfaces, websites, and device software. Poorly localized content can lead to regulatory delays, misinformed use, safety risks, product recalls, and financial losses.

But localization extends well past “feeling the heat” of regulatory compliance and risk management. Device manufacturers increasingly recognize that properly adapted content builds patient trust, improves clinician effectiveness, and smooths the pathway for device adoption and growth across markets.

TransPerfect’s Medical Device Localization Solutions

To help device manufacturers address these evolving challenges, TransPerfect delivers a comprehensive suite of medical device localization solutions that integrate industry-leading expertise, rigorous quality assurance, and state-of-the-art technology.

Our solutions are built on ISO 13485, 14971, 9001, 18587, and 17100 certified language services, ensuring the highest standards for medical translation, terminology management, and document traceability.

This foundation is strengthened by TransPerfect’s QA, Testing & Accessibility Center of Excellence, which combines in-market language expertise, rigorous functional testing, and digital accessibility support to deliver confident compliance and strong end-user experiences.

TransPerfect’s GlobalLink technology suite further streamlines the management and deployment of localized content across software, mobile apps, websites, and device interfaces. The result: faster go-to-market timelines and rapid, compliant content updates. With customized technology integration, timeline reductions of 40% or more have been achieved.

Medical Device Localization for Regulatory Compliance

Regulators such as the US FDA, EU Notified Bodies, and China’s NMPA require region-specific content that meets technical, linguistic, and accessibility standards. As connected devices and software become central to care delivery, digital health localization is no longer optional. It’s essential to meeting regional compliance standards and user expectations.

Medical Device Localization for Provider and Patient Engagement

Healthcare providers and patients increasingly interact with medical devices through digital interfaces. The information presented must feel intuitive, trustworthy, and relevant. Poor translation or insufficient adaptation can lead to confusion, user error, and non-compliance that ultimately impacts clinical outcomes and satisfaction.

Key Components of a Robust Medical Device Localization Strategy

TransPerfect ensures regulatory and business requirements are met holistically through certified translation, in-language user testing, and advanced localization management technology.

A strong localization strategy includes:

1. Certified Translation
   Specialized medical device translation services (certified to ISO 13485, 14971, 9001, 17100, and 18587) covering digital assets, software, labeling, and support materials.
2. Cultural and Regulatory Adaptation
   Adjusting measurement units, content structure, visuals, and workflows to align with local norms and regulations.
3. Design and User Experience Localization
   UX/UI adaptation for diverse languages, including right-to-left languages and accessibility conformance, supported by in-house QA and accessibility experts.

4. Validation and Testing
   In-market language validation, functional testing, and comprehensive review for compliance and usability.

5. Ongoing Content Management
   Automated solutions that enable rapid, compliant updates in response to regulatory changes or new clinical information.

Real-World Localization Challenges and Solutions

1. Ensuring Accuracy in Digital Health Apps and Software
   When device software or mobile apps lack accurate translation and cultural adaptation, critical alerts or instructions may be misunderstood in ways that can increase the risk of an adverse event. TransPerfect’s in-market language and functional testing, combined with GlobalLink Strings (part of the GlobalLink technology suite), ensures accuracy and safety before deployment.
2. Addressing Digital Accessibility and Multilingual UX
   If a device app or site fails to handle language expansion, right-to-left text, or accessibility requirements, users may be left behind. TransPerfect’s accessibility and UX experts apply internationalization best practices through pseudo-localization and multi-market UX testing.
3. Achieving Consistent Global Brand Messaging
   Without standardized glossaries, translation memories, and style guides, companies risk fragmented messaging across markets. TransPerfect’s enterprise terminology management and localization technology help maintain brand consistency across all touchpoints.
4. Adapting to Constant Regulatory and Content Changes
   Medical device content must be updated whenever new safety information is issued—and in the case of an FSN, often under urgent timelines. TransPerfect’s automated content management and translation platforms enable rapid, compliant rollouts across formats and markets.

Building Strategic Advantage Through Localization

Medical device localization is a complex undertaking that requires regulatory expertise, specific technical resources, and deep understanding of local markets.

With ISO-certified language services, robust QA and accessibility testing, and the GlobalLink technology suite, organizations can confidently navigate global compliance while building trust with providers and patients worldwide.

Investment in comprehensive localization today will help define the market leaders of tomorrow.

Real-World Example: Scaling Across European Markets

A medical device company required localization support to expand its products into multiple European markets. Here’s how the engagement unfolded:

1. Defining the Scope
   The mobile app and website were only the beginning. Training materials, IFUs, supplemental PDFs, videos, and other documentation all required localization. AI-enabled workflows were introduced to accelerate processes while maintaining quality.
2. Style Guide and Glossary Creation
   Before translation began, key terminology and brand style preferences were aligned for each target language, creating a strong foundation for consistency and compliance.
3. Technology Integration
   TransPerfect’s GlobalLink technology suite was integrated directly into the client’s existing tech stack, enabling automated file transfer, in-country review workflows, and post-localization testing.
4. Streamlined Translation Workflows
   With scope defined, linguistic assets created, and integration in place, translation processes moved efficiently and predictably.
5. Content Reuse and Optimization
   GlobalLink enabled intelligent reuse of repetitive content across platforms, content types, and end uses—improving efficiency and reducing costs.
6. Results
   Centralized assets and streamlined processes delivered measurable impact:
   • $200K+ annual cost savings
   • 40–60% reduction in turnaround times though AI-enabled workflows
   • 3M+ words translated

Ready for a Translation and Localization Strategy That Scales?

Expanding into new markets doesn’t have to mean navigating compliance and localization challenges alone.

Whether you’re preparing for MDR/IVDR expansion, launching a connected device, or scaling digital health content globally, TransPerfect can help you build a localization strategy that protects your organization and strengthens engagement across markets.

Connect with our medical device localization experts to discuss your global growth plans.