CEO MDR Regulator, Board Member Pure Clinical
Katarzyna Wesołowska is a leader and expert in the MedTech industry with over a decade of experience navigating the complex landscape of medical device regulation, quality assurance, and clinical trials. As the CEO of MDR Regulator and Board Member of Pure Clinical, Katarzyna spearheads strategic consulting initiatives, helping organizations meet rigorous regulatory and clinical standards while accelerating the successful market entry of innovative medical technologies.
With expertise spanning regulatory and clinical compliance, CE marking, and ISO quality management systems, Katarzyna has conducted over 50 certification and surveillance audits and provided consultancy to more than 100 MedTech companies globally. Her experience includes working with manufacturers, importers, and notified bodies, giving her a 360-degree perspective on the lifecycle of medical devices and in vitro diagnostics (IVDs).
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.
At the conference, Katarzyna will share insights focusing on regulatory trends, quality assurance best practices, and MedTech innovation strategies.
