Medical Devices

In order to sell their products globally, medical device manufacturers need to adapt the entire product for presentation in a foreign market.

However, even before your device is ready for global marketing, you have to conduct clinical trials internationally. The documentation for clinical trials must conform with the requirements of the FDA, EMEA and other regulatory organizations.

Regulators require that patient recruitment materials, Informed Consent Forms (ICF), clinical protocols and other documents be in a language that is clearly understood by the participants of clinical studies.

A need to market your device internationally, combined with requirements for regulatory compliance, creates an imperative for precise, culturally-sensitive translations of documents.

We understand the demands of the marketplace and can help you clear these hurdles.

We translate a wide variety of medical device documents:

• Patents and contracts
• User guides
• Product Manuals and Instructions
  
• Patient recruitment documents
• Clinical trial protocols
• Informed Consent Forms (ICF)
• Case Report Forms (CRF) and Adverse Event Reports
• IRB/IEC documentation
• Scientific journal articles
• Manufacturing SOPs
• Other documents requiring localization, including manufacturing, marketing and legal materials

Please call us to discuss your project: US Toll Free: (877) 731-6332

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