Ilona Korczak-Cegielska

Ilona serves as the Director of Clinical and Regulatory Operations at Pure Clinical. Active in the medical device industry since 2010, she oversees clinical and regulatory projects, including the design and conduct of clinical investigations in compliance with MDR 2017/745, ISO 14155, and ICH GCP E6 (R2). She has extensive experience in preparing technical documentation, supporting CE certification processes, and successfully bringing medical devices to market. Ilona holds a PhD in Biomedical Engineering from the Polish Academy of Sciences and earned her engineering degrees from Wrocław University of Science and Technology and Warsaw University of Technology. She also completed postgraduate studies in Biomaterials – Materials for Medicine at AGH University of Science and Technology in Kraków. An ISO 13485 internal auditor, author, and co-author of scientific publications and patents, she combines technical expertise with strategic leadership to drive innovative projects at Pure Clinical.

Ilona Korczak-Cegielska

Ilona Korczak-Cegielska

Director of Clinical and Regulatory Operations

Education (4)

Polish Academy of Sciences

Doctor of Philosophy (PhD), Biomedical Engineering

2017 – 2021

AGH University of Krakow

Postgraduate studies, Biomaterials - Materials for medicine

2017 – 2018

Warsaw University of Technology

Master's degree (MSc), Biomedical Engineering

2014 – 2016

Wroclaw University of Science and Technology

Engineer's degree (Eng.), Biomedical Engineering spec. Biomechanical Engineering

2010 - 2014

Work Experience (5)

Pure Clinical

Head of Clinical Unit | MD

V 2024 – currently

Clinical Trial Manager

VI 2022 – IV 2024

Konmex sp. z o.o.

Coordinator of the R&D Department

I 2022 – V 2022

Constructor

IV 2017 – XII 2021

Junior Constructor

I 2016 – III 2017

Polish Academy of Sciences

Industry Doctoral Student

X 2017 – XII 2021

EMED sp. z o.o. sp.k.

Biomedical Engineer

VII 2015 – XII 2015

Research Program Visiting Student

International Research Center on Mathematics and Mechanics of Complex Systems “M&MoCS”

II 2015 – III 2015

Publications (4)

Gambin B., Korczak-Ciegielska I., Secomski W., Kruglenko E., Nowicki A., Ultrasonic Experimental Evaluation of the Numerical Model of the Internal Fluid Flow in the Kidney Cooling Jacket, ARCHIVES OF ACOUSTICS, ISSN: 0137-5075, DOI: 10.24425/aoa.2022.142004, Vol.47, No.3, pp.389-397, 202.

Korczak I., Romowicz A., Gambin B., Palko T., Kruglenko E., Dobruch-Sobczak K., Numerical prediction of breast skin temperature based on thermographic and ultrasonographic data in healthy and cancerous breasts, Biocybernetics and Biomedical Engineering, ISSN: 0208-5216, DOI: 10.1016/j.bbe.2020.10.007, Vol.40, pp.1680-1692, 2020.

Korczak I., Gambin B., Kruglenko E., Aktualności Inżynierii Akustycznej i Biomedycznej, rozdział: Stabilizacja temperatury organu podczas zabiegu transplantacji, Polskie Towarzystwo Akustyczne, Oddział w Krakowie, I, pp.97-103, 2018.

Kruglenko E., Korczak I., Gambin B., Aktualności Inżynierii Akustycznej i Biomedycznej, rozdział: Efektywność hipertermii ultradźwiękowej w agarowych wzorcach tkanki miękkiej domieszkowanych różnymi składnikami, Polskie Towarzystwo Akustyczne, Oddział w Krakowie, I, pp.105-113, 2018.