Karolina Stypułkowska

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.