This article focuses on the FDA approval process for medical devices, providing a step-by-step guide to accessing the US market.
This article provides information on the new EU Market Surveillance Regulation 2019/1020, coming into force on July 16th, 2021.
This article helps you understand what an EU authorised representative is and what their general responsibilities are.
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.