Katarzyna Wesołowska
Kasia serves as a Board Member at Pure Clinical. She specializes in medical device certification, ISO 13485 quality systems, auditing, regulatory affairs, SaMD, and FDA compliance. With 9 years of experience in the medical device sector, she combines regulatory expertise with practical experience in certification management, conformity assessment, and preparation of clinical and technical documentation in accordance with applicable regulations. 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