2021-03-02
This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.
2020-05-27
This article provides a brief overview of what a technical file is and what it should contain. Special attention will be given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.