Bio
She has been involved in matters related to in vitro diagnostic medical devices since 2016. She has repeatedly participated in various stages of the IVD device lifecycle, from designing and manufacturing to obtaining CE IVD certification.
She is a graduate of Biotechnology at Warsaw University of Technology and Clinical Research Methodology at Warsaw Medical University.
She has expertise in conducting clinical performance and analytical studies planned following Regulation 2017/746 (IVDR) and requirements in other countries. Her experience includes designing and monitoring studies and documentation design under Good Clinical Practice and ISO 20916:2019.
She has prepared Technical Documentation for devices and participated in implementing ISO 13485:2016 and ISO 14971:2019. She has coordinated teams planning and conducting study projects for IVD devices in various diagnostic areas, covering risk classes from A to D.