Katarzyna Wesołowska
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 Vice-president 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 Pure Clinical, she provides strategic support to medical device and IVD manufacturers in preparing for clinical investigations and meeting regulatory requirements to successfully bring innovative products to market. Previously, she worked as a quality and regulatory consultant and medical device auditor at an EU Notified Body, where she managed certification projects, evaluated technical documentation (including clinical evaluation, risk analysis, and biocompatibility), and liaised with the European Commission and competent authorities. She holds a Master’s degree in Biomedical Engineering from the Warsaw University of Technology and completed postgraduate studies in Clinical Research Methodology at the Medical University of Warsaw.
Katarzyna Wesołowska
Education (3)
Warsaw Medical University
Warsaw Medical University, Clinical Research Methodology
2015 - 2016
Warsaw University of Technology
Biomedical Engineering
2014 – 2015
Bialystok University of Technology
Biomedical Engineering
2010 – 2014
Work Experience (5)
MDR
Chief Executive Officer
sty 2021 – obecnie
Pure Clinical Sp. z o. o.
Co-Chief Executive Officer / Co-Founder
wrzesień 2021 - obecnie
Reha Fund Sp. z. o. o.
Quality Management System Representative / Quality and Regulatory Affairs Specialist Quality Management System Representative / Quality and Regulatory Affairs Specialist
sty 2020 – sie 2021
Licenses & Certificates (22)
Analysis and assessment of medical devices test results (biological, chemical, electrical) and evaluation of raw materials
Związane z Polskie Centrum Badan i Certyfikacji S.A.
Application of usability engineering to medical devices – PN-EN 62366-1:2015
Związane z Polskie Centrum Badan i Certyfikacji S.A.
Basics of pharmacology
Związane z Medical University of Warsaw - MUW
Courses (1)
Analysis and assessment of medical devices test results (biological, chemical, electrical) and evaluation of raw materials
Związane z Polskie Centrum Badan i Certyfikacji S.A.
Publications (2)
Analysis and assessment of medical devices test results (biological, chemical, electrical) and evaluation of raw materials
Związane z Polskie Centrum Badan i Certyfikacji S.A.
AGH University of Krakow
Postgraduate Degree, Biomaterials - materials for medicine
paź 2023 – cze 2024