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