Technical documentation

We provide technical documentation support (preparing and writing of the dossier) throughout the entire lifecycle of your product, spanning both the pre-submission and the post-submission phases.

In the pre-submission phase, our regulatory experts will perform a gap analysis and assess the required technical documentation according to various regulations.

They will compile documentation for the Design History File.

They will prepare & write the technical file for submission to authorities.

After CE marking or FDA approval, Eurofins Medical Device Consulting can maintain this technical documentation for you. This includes change assessment documentation updates, technical file and design history file maintenance, as well as communication with authorised representatives and competent authorities (e.g. FDA).