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What languages of product documentation are required for MDSAP certification in the United States?
Category：企業(yè)動態(tài) Date：2024-11-25 17:22:28 Author: Source:
?For MDSAP certification in the United States, product documentation typically needs to be provided in English. This includes the device's technical file, labeling, and quality management system (QMS) documentation. While other languages may be acceptable for submission in certain regions (like Japanese or French for other MDSAP countries), English is the primary language required for the U.S. market. It is essential that all documents, including instructions for use (IFU), design specifications, and risk management files, be available in English for compliance with FDA and MDSAP standards.

For MDSAP certification in the United States, product documentation typically needs to be provided in English. This includes the device's technical file, labeling, and quality management system (QMS) documentation. While other languages may be acceptable for submission in certain regions (like Japanese or French for other MDSAP countries), English is the primary language required for the U.S. market. It is essential that all documents, including instructions for use (IFU), design specifications, and risk management files, be available in English for compliance with FDA and MDSAP standards.

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