Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe

Here, we share the insights and challenges we encountered during the implementation of an appropriate and efficient QMS for academic research, which we believe can serve as a guiding example for other academic research groups. By presenting our QMS implementation validated by an MPA clinical investigation approval, we aim to raise awareness about the pivotal importance of MDR compliance among researchers in Europe. Our contribution seeks to provide a roadmap for fellow research groups in navigating the evolving regulatory landscape while sustaining their focus on groundbreaking research and innovation in the field of biomedical engineering.