Bio
At MDR Regulator, Karolina is an expert responsible for biocompatibility and clinical evaluation of medical devices, especially being a mixture of substances or devices with medicinal substance. On a daily basis, she deals with qualification and classification of medical devices and verification of technical documentation for compliance with Regulation (EU) 2017/745. She is also responsible for analytical testing of medical devices and legal aspects related to medical devices, especially borderline products. She is also ISO 17025 auditor.
She is a graduate of Pharmacy at the Medical University of Warsaw, where she also received her doctorate in pharmaceutical sciences. She specializes in quality testing of medicinal products, - supplements and medical devices - to ensure their high quality.
She has co-authored 10 scientific publications and a textbook for students - „Forensic Analytics”.
She enjoys spending her free time sightseeing with her children. She loves to read books.
Selected scientific publications
- Stypulkowska K. et al. Selectivity of identification of compounds from the group of phosphodiesterase 5 inhibitors (PDE-5i) in falsified products from the Polish market using attenuated total reflectance Fourier transform infrared spectroscopy and X-Ray powder diffraction. Science & Justice 61 (2021): 714-722. https://doi.org/10.1016/j.scijus.2021.08.008
- Stypulkowska K., Piorunska-Sedlak K., Strategy for identification of new psychoactive substances in illicit samples using attenuated total reflectance infrared spectroscopy. Forensic Science International 312 (2020) 110262 https://doi.org/10.1016/j.forsciint.2020.110262
- Stypułkowska K i wsp. Analiza ilościowa antybiotyków aminoglikozydowych i ich zanieczyszczeń – wyzwania i nowe kierunki. Farm Pol, 2016, 72(4): 260-268.
- Stypulkowska K. et al. Determination of neomycin sulfate and related substances in pharmaceutical preparations by reversed-phase high performance liquid chromatography with mass spectrometry and charged aerosol detection. J Pharm Biomed Anal 76 (2013): 207-214. https://doi.org/10.1016/j.jpba.2012.12.025