Expanding globally in the medical device industry requires more than just product innovation. It demands flawless communication, absolute regulatory precision, and deep cultural understanding. When lives are on the line, and regulatory bodies are watching, there's no room for error in your translations.
That’s why medical device companies choose Rapport International.
Medical device companies face strict documentation requirements across markets: FDA submissions, EU MDR compliance, ISO 13485 documentation, and more. One small mistranslation in an Instruction for Use (IFU) or package insert can delay approvals, damage your brand, or even endanger patients.
Rapport International delivers:
Expert human translation by industry-specialized linguists
Adherence to ISO 17100 and ISO 13485 standards
Terminology management and consistency checks
Our teams understand the exact phrasing regulatory bodies expect—because we've done it before, successfully, many times.
AI-generated or low-cost translations often miss the mark, especially with medical terminology that doesn't map 1:1 across languages. Rapport uses professional, in-country linguists who grasp the linguistic and cultural nuances vital to patient safety and legal clarity.
We ensure:
Contextually accurate terminology
Region-specific phrasing
Cultural sensitivity in patient-facing materials
Every translation is reviewed and validated for local relevance.
We’re not generalists. Our translators and project managers specialize in:
Instructions for Use (IFUs)
Device labeling and packaging
Clinical trial documentation
Regulatory filings and submissions
Website and digital content
We serve medtech clients across the U.S., Europe, and Asia with unmatched consistency, reliability, and compliance.
When time-to-market matters, Rapport helps you scale efficiently. We assign dedicated teams who learn your brand, voice, and documentation style, and we manage complex multilingual projects with ease.
You get:
One point of contact
Streamlined workflows
On-time, on-budget delivery
We act as an extension of your team.
We believe translation is personal. Rapport International is built around human relationships, trust, and collaboration. Unlike faceless agencies or AI-only solutions, we provide continuity, care, and responsiveness.
That’s why our medtech clients stay with us for years—often decades.
Don’t trust your medical device translations to just anyone. Choose the partner who understands the stakes. Learn more about how we work with medical device companies.