MDD → MDR! Have you completed the MDR compliance for various types of documents (including translation and others)?
Our company will comply with the Medical Device Regulation (MDR) that will be applicable from May 2020. The MDR requires the establishment of a quality management system, the creation of technical documentation, the implementation of risk management, the preparation of labels and IFUs (Instructions for Use), the conduct of clinical evaluations, and the establishment and documentation of procedures related to post-market surveillance and post-market studies. We can assist with translations into English and other official languages of European countries, as well as translations that cover harmonized standards, and translations utilizing existing documentation (your company's software assets) to address your needs. 【Items Handled】 ■ Medical Device QMS Documents ■ Technical Documentation ■ Risk Management Documents ■ IFU Documents *For more details, please download the PDF or contact us.
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basic information
"Are you having trouble with something like this?" - Translation into English and other official languages of European countries - Translation covering compliance standards - Translation utilizing existing documents (your company's software assets) - Native language checks for each language - Compliance of IFU with relevant standards, etc. *For more details, please download the PDF or contact us.*
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For more details, please download the PDF or contact us.
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Company information
Our company provides services related to the MDR Annex and the documents to be translated, including translation and native check support, editing, writing, and compliance support. Please feel free to contact us if you have any requests.