Do you work with in-house regulatory or localization teams?

Yes. We frequently collaborate with internal regulatory, quality, and localization teams, fitting into existing approval workflows rather than replacing them.

How do you handle terminology for medical devices?

We build and maintain dedicated termbases approved by your SMEs and regulatory teams, ensuring consistent use of device names, safety terms, and clinical language.

Can you support clinical and performance evaluation documents?

Yes. We translate clinical evaluation reports, performance summaries, and supporting evidence with linguists experienced in medical and scientific content.

How do you reduce risk in high-impact medical content?

We apply risk-based workflows, additional review steps, and stricter QA for high-risk content like IFUs, labeling, and safety information.

How do you ensure audit readiness?

All projects include traceable workflows, version control, and documented QA steps so you have clear records for audits or submissions.

Can you scale for large global submissions?

Yes. We support multi-country submissions and large language sets using scalable workflows and centralized terminology control.

Do you support long-term lifecycle management?

Yes. We can work with you across the full device lifecycle, from development to post-market updates.

Medical Device Translation Services (ISO-Compliant & MDR-Ready)

Medical Devices
Translation Services

Launch medical devices safely and quickly across markets with translation that’s accurate, compliant and secure.

Launch Globally With Confidence

Multilingual content in medical devices is high stakes. From IFUs and DFUs to software UI and post-market reports, every word must meet regulatory expectations and be clear to real users.

How We Help

We combine specialist linguists, medical device SMEs, and a secure enterprise platform with an AI-enabled layer. This delivers faster turnaround, consistent terminology, and audit-ready workflows that support market approvals and ongoing updates.

Medical device translation services mapped to risk and document type
Terminology governance for product, safety and labeling content
Secure, traceable production that fits your QMS and supplier controls
Flexible service levels, including ISO 17100 translation with review and ISO 18587 MTPE where appropriate

Localization for the
Full Device Lifecycle

MedTech Translation Designed for Regulatory Compliance

In this field, localization is risk management.

Our workflows are designed to support supplier controls, traceability and audit readiness.

We align service level to content risk, apply controlled terminology, run automated QA checks, and capture feedback so every update improves your terminology assets and translation memory.

The Process

Our workflow is built to keep translations accurate, consistent and audit-ready from the start.

We align on risk, terminology and context upfront, then combine specialist linguists with STREAM AI’s secure environment and automated QA to deliver reliable outputs at speed.

Feedback is captured cleanly, updates flow into your terminology and Translation Memory, and every file is fully traceable so you receive submission-ready content with minimal rework.

How MedDev Content Is Typically Scoped

Not all medical device content carries the same regulatory or patient risk.
Effective localization programs scope work based on impact and use. For example:

High-risk content IFUs, safety information, and labeling often require full human translation, multi-step review, and strict terminology control.

Medium-risk content Technical documentation or training materials may combine specialist translation with structured QA.

Lower-risk content Internal or reference materials can sometimes use lighter workflows while maintaining terminology consistency. A risk-based approach helps balance compliance, speed, and cost — while keeping patient-facing and regulatory content under the highest controls.

How We Measure Translation Quality

We use Multidimensional Quality Metrics to track accuracy, terminology, fluency, style and locale conventions. Scores feed root-cause analysis and continuous improvement inside STREAM AI.

Security

Your content is protected with enterprise level security and audited controls. We operate under HITRUST r2 and ISO-based information security programs and align our processes to your unique requirements.

alignment for documentation and supplier controls

for translation services

for machine translation post-editing where acceptable

Built for Compliance, Speed & Consistency

Our hybrid model combines specialist linguists, medical device SMEs, and STREAM AI, our secure enterprise translation platform.

You get:

ISO 17100 translation or ISO 18587 MTPE depending on risk
Centralized terminology governance and medical terminology control
Streamlined handoffs that fit your QMS and supplier controls
Faster turnaround times without losing regulatory precision
Audit-ready processes aligned to ISO 13485

FAQ

STREAM AI

Built For High-Risk Content.
Trusted For Medical Device projects.

STREAM AI, our proprietary platform, unifies translation memory, term bases, machine translation and automated QA in a secure workspace. It gives linguists context, flags critical issues early and keeps assets synchronized across projects so each release builds on the last.