Translations for Medical Device Companies: Unlocking Global Success Across Departments

For medical device companies professional translation services ensure their products are understood, trusted, and accessible across their major target markets. From regulatory compliance to surgeon training, here’s how different departments in a medical device company benefit from professional translation, and how it helps build stronger connections with customers and healthcare professionals worldwide.

1. Regulatory Affairs

Every country has its own regulatory requirements. Whether it’s CE marking in Europe or FDA submissions in the U.S., accurate translations of technical documentation, Instructions for Use (IFUs), and safety labels are essential. Poor translations can delay approvals or even lead to product recalls. High-quality translations ensure your devices meet international standards and reach markets faster.

• Why: To prepare and submit documentation for regulatory approvals in different countries.
• Examples: Instructions for Use (IFUs), regulatory submissions (e.g., CE marking, FDA), labeling, and safety documentation.

2. Marketing and Communications

Marketing teams rely on translation to localize brochures, websites, videos, and social media content. It’s not just about language, it’s about cultural relevance. Localized marketing builds trust and credibility with surgeons, hospital administrators, and patients. It can relay pivotal information as well to end users about product updates.

• Why: To localize marketing materials for global audiences.
• Examples: Brochures, websites, social media content, product videos, and advertising campaigns.

3. Clinical Affairs

Clinical trials often span multiple countries. Translation is needed for patient consent forms, trial protocols, and investigator brochures. Clear and accurate translations protect patient rights and ensure ethical standards are upheld, while also streamlining trial operations across borders.

• Why: To support clinical trials and studies in multiple regions.
• Examples: Patient consent forms, clinical trial protocols, investigator brochures, and study reports.

4. Customer Support / Technical Support

Support teams need multilingual resources like troubleshooting guides, FAQs, and training videos to assist users around the world. When a surgeon or technician needs help, they need it fast and preferably in their native language. Translations reduce downtime and improve user satisfaction.

• Why: To assist international customers and healthcare professionals.
• Examples: FAQs, troubleshooting guides, customer service scripts, and training materials.

5. Quality Assurance (QA) and Quality Control (QC)

QA teams rely on translated SOPs, audit reports, and quality manuals to ensure consistent processes across global facilities. Standardized, translated documentation helps maintain product quality and safety, no matter where your team is located.

• Why: To ensure quality documentation is accessible and compliant across regions.
• Examples: Standard Operating Procedures (SOPs), audit reports, and quality manuals.

6. Training and Education

Whether it’s onboarding new distributors or training surgeons on a new device, translated e-learning modules and manuals are key. Proper training reduces misuse and improves outcomes. When practitioners fully understand the device and its application, both providers and patients benefit.

• Why: To train healthcare professionals and internal staff globally.
• Examples: E-learning modules, training manuals, and certification materials.

7. Legal and Compliance

Legal teams need translated contracts, privacy policies, and compliance documents to operate safely in international markets. Accurate legal translations reduce risk and ensure your company is protected in every jurisdiction. Accurate legal translations reduce risk and ensure your company is protected in every jurisdiction.

• Why: To ensure legal documents are understood and enforceable in different jurisdictions.
• Examples: Contracts, terms of service, privacy policies, and compliance documentation.

Be Prepared to Say it in Another Language

Medical device companies must consider their target audiences beyond international markets including surgeons, hospital staff, patients, and regulatory bodies. For example, expanding into the European Union (EU) could involve translating materials into any one of the twenty four official languages. Yet providers and patients may need additional languages or dialects for your medical device to truly find success in a given region.  Translation services play a critical role in making product information, training materials, and regulatory documentation accessible and compliant. Making them apart of your product lifecycle enables your medical device company to:

• Enter new markets confidently
• Build trust with global customers and surgeons
• Ensure safety, compliance, and quality
• Deliver a consistent brand experience worldwide

Interested in how iTi’s professional translation services can work for your business? Contact us today to get started.

Interpreters and Translators, Inc. is a full service language solutions company based in Glastonbury, Connecticut. iTi is an NMSDC-certified minority owned business.