Regulation & Compliance
Regulatory requirements for the translation of medical device instructions for use.
EU MDR 2017/745
Language and Translation Requirements of the Medical Device Regulation
5 requirements · 3 FAQs
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EU IVDR 2017/746
Language and Translation Requirements for In Vitro Diagnostics
5 requirements · 3 FAQs
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ISO 13485:2016
Quality Management System Requirements and Their Relevance to Translation
4 requirements · 2 FAQs
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IEC 62366-1:2015
Usability Engineering and Its Impact on IFU Translation
4 requirements · 2 FAQs
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eIFU Regulation (EU) 207/2012
Requirements for Electronic Instructions for Use for Medical Devices
4 requirements · 2 FAQs
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ISO 14971:2019
Risk Management for the Translation of Medical Device Instructions for Use
4 requirements · 2 FAQs
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