Bio
Katarzyna Wesołowska is a leader and seasoned professional in the MedTech industry, with over ten years of experience in medical device regulation, quality assurance, and clinical trials. As the CEO of MDR Regulator and a Board Member of Pure Clinical, she drives strategic initiatives that enable organizations to navigate complex regulatory landscapes, achieve clinical compliance, and bring groundbreaking medical technologies to market.
Katarzyna’s expertise encompasses regulatory compliance, CE marking, ISO quality management systems, and clinical validation. She has led more than 50 certification and surveillance audits and advised over 100 MedTech companies worldwide. Her comprehensive industry knowledge stems from hands-on experience with manufacturers, importers, and notified bodies, providing her with a holistic view of the medical device and in vitro diagnostics (IVD) lifecycle.
Holding advanced degrees in biomedical engineering and clinical trials methodology from institutions such as the Warsaw University of Technology and Medical University of Warsaw Katarzyna combines technical depth with business acumen. Her leadership and passion for innovation drive her commitment to supporting clinical research organizations and fostering high-quality healthcare solutions.