Katarzyna Romaniszyn
A graduate of the University of Łódź, Faculty of Biology and Environmental Protection, with a specialization in Microbiology, and of postgraduate studies at the Lodz University of Technology, Faculty of Organization and Management, in the field of Management and Quality Management Systems. She has over 13 years of experience in Quality Management Systems in the medical and food industries. For the past 9 years, she has been involved in the medical device sector, particularly in the area of higher-class non-active devices, implantable products, and advanced wound dressings. From 2014 to 2022, she served as Management Representative for Quality Management Systems, Safety, and Medical Device Registration. She is responsible for managing a team of experts, developing project implementation strategies, overseeing organizational aspects of consulting projects in the medical device sector, verifying the compliance of technical documentation with regulatory requirements for medical devices, and preparing and reviewing Quality Management System documentation in accordance with ISO 13485 and ISO 9001. She also conducts training on medical devices and ISO 13485 Quality Management Systems.
