This course teaches the technical dossier preparation processes under the Medical Device Regulation (MDR) 2017/745 (EU). The course provides detailed information on the scope of the technical dossier, required documents, clinical evaluation reports and declarations of compliance.

Participants learn how to prepare the documents required to prove that their products comply with the regulatory requirements. In this way, they will have the necessary knowledge and skills to overcome potential barriers to entry of medical devices into the European market.