Sára Barboríková is a researcher at the CTU UCEEB and a PhD student in Assistive Technology at the Faculty of Biomedical Engineering, CTU. Her dissertation focuses on the certification of medical devices in the context of European MDR, EHDS and NIS2 regulations. In addition to her academic work, she is a regulatory consultant in the field of medical devices, where she specializes in the preparation of technical documentation, implementation of quality management systems according to ISO 13485 and communication with regulatory authorities. She has experience in internal auditing according to EN ISO 19011 and has acted as a compliance officer in medical device companies.