All medical devices, regardless of their classification, require a clinical evaluation to demonstrate the acceptability of the risks associated with…

The first step in preparing the TD is to create a Technical Documentation template that allows for the inclusion of…

For all medical devices except custom-made devices, manufacturers are required to draft and maintain up-to-date Technical Documentation in accordance with…

The introduction of reporting requirements for post-market surveillance (PMS) by the MDR necessitates a more coherent, standardized, and systematic review…