2021-04-13
Learn what a medical device risk management plan is and how to create one.
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.
2021-02-16
MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.
2021-02-11
This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.