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Technical Documentation for CE Marking by Hyacinthe KOSSI is a document available to read on EtoBox.

What is Technical Documentation for CE Marking about?

This technical document structure poster outlines the key elements that must be included in a medical device technical file according to Annex II of the EU Medical Device Regulation (MDR) 2017/745. The technical file must include: 1) Device description and specifications, 2) Materials and ingredients, 3) Design and manufacturing information, 4) General safety and performance requirements documentation, and 5) Validation and performance testing data. The technical file must be presented in a clear, organized

Author

Hyacinthe KOSSI

Language

EN