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From IFUs and product labels to e-labeling and regulatory documentation, our specialized medical translation services ensure accuracy, consistency, and full compliance with global standards — so your devices reach international markets safely and efficiently.
Medical device translation is the specialized process of accurately translating Instructions for Use (IFUs), labels, e-labels, software, packaging, and regulatory documentation into multiple languages to meet international compliance requirements and ensure patient safety.
This type of translation goes beyond words. It demands deep knowledge of medical terminology, ISO 13485 standards, MDR/IVDR regulations, and country-specific labeling laws. Errors in translation can lead to regulatory delays, product recalls, or harm to end users.
A trusted medical device translation partner ensures:
Whether you're preparing for EU MDR submissions or launching devices across Asia or LATAM, medical device translation is essential for market access and brand integrity.
Inaccurate translations in MDR (Medical Device Regulation) or IVDR (In Vitro Diagnostic Regulation) submissions can delay product approvals, trigger costly rework, or even result in market rejections and recalls.
Under MDR and IVDR, the European Union requires precise, harmonized, and localized documentation in each target market’s official language. This includes:
Even minor translation errors can lead regulators to question product safety, device performance, or manufacturer reliability—jeopardizing your path to compliance.
Working with expert medical device translators ensures:
Accuracy isn’t optional—it’s critical for MDR/IVDR success.
We’re fully certified under ISO 13485, ISO 17100, and ISO 27001, meeting the highest international standards for quality, safety, and data security—critical for regulatory compliance and audits.
Our linguists aren’t just native speakers—they’re subject-matter experts with backgrounds in biomedical, technical, and life sciences, reducing the risk of translation errors that could compromise patient safety or regulatory approval.
We specialize in medically regulated markets, including Europe and the U.S. Our team understands the nuances of MDR, IVDR, FDA, and EMA requirements, helping you avoid costly delays and compliance issues.
We follow strict protocols aligned with HIPAA, GDPR, and ISO 27001, safeguarding sensitive patient data, device specifications, and proprietary materials throughout the translation process.
- CEO, Unibloc Pump
- Creative Services Manager, Gerson
- Marketing Content Manager, AutoStore
- Director of Marketing, Berlin Packaging
- EVP and GM, Ranfac