Medical Devices

Precision while translating projects for medical devices is not just important, it is a necessity. 


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Translating medical device documents poses many risks of technical error, cultural incompetence, and regulatory discrepancies as you cross borders. CSOFT overcomes these barriers by using ISO certified software and subject matter experts to communicate your device’s functions and capabilities to a cross cultural and multilingual market. CSOFT will provide translation services to your company in every stage from engineering all the way to corporate training.

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CSOFT's proven expertise in high-quality technical translation for the life sciences industry is backed by our ISO 9001:2015 and ISO 13485:2016 certified quality management system.

Medical Device Translation

  • Operating, Maintenance and Installation
  • Development Safety Update Reports (DSURs)
  • Instruction for Use (IFUs)
  • Regulatory Compliance Documents for European Union and Asia
  • Package Inserts and Labels
  • Patents for Medical and Surgical Devices
  • Manufacturing Process Descriptions
  • Training Materials

Our Methodology

CSOFT works with highly experienced and knowledgeable medical experts and translators to write and edit your device’s documents. These translators are versed in the regulations to enter a country’s market and are chosen on a case-by-case basis to ensure that your documents are receiving the most relevant attention.

Our experts translate many different types of documents related to your medical devices including labelling, clinical trial results, informed consent forms, and product manuals and guides for use.