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

  1. 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.
  2. 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
  3. Stypułkowska K i wsp. Analiza ilościowa antybiotyków aminoglikozydowych i ich zanieczyszczeń – wyzwania i nowe kierunki. Farm Pol, 2016, 72(4): 260-268.
  4. 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.