Katarzyna Wesołowska
She has nine years of experience in the medical industry.
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 CRO of Pure Clinical, she is involved in
preparing medical device and in vitro diagnostic device manufacturers for clinical trials and meeting
regulatory requirements to bring innovative medical devices to market.
Previously a Quality and Regulatory Consultant and medical device auditor and specialist in inactive
implantable, invasive, as well as active devices at the Notified Body. As part of her work at the
Notified Body of the EU, 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.
