BIO

She holds a master’s degree in Biomedical Engineering from the Warsaw University of Technology and a postgraduate degree in Clinical Research Methodology from the Warsaw Medical University.

As part of the consulting company MDR Regulator and the company CRO – Pure Clinical, she is involved in preparing manufacturers of medical devices and in vitro diagnostic devices for clinical trials and meeting regulatory requirements in order to market innovative medical devices. Since the beginning of her career, she has been involved in the medical industry: in cooperation with medical device manufacturers and notified bodies.

Previously Quality and Regulatory Consultant and medical device auditor and specialist for implantable, invasive as well as active inactive devices at the Notified Body.

As part of her work at the EU Notified Body, she was responsible for leading medical device certification projects, creating requirements for the evaluation of medical device documentation including clinical evaluation, risk analysis and biocompatibility testing, liaising with the European Commission and Polish regulatory authorities.