Katarzyna Romaniszyn

Kasia serves as the Head of Regulatory and Quality Management Department at Pure Clinical. She is responsible for managing a team of experts, developing project execution strategies, and overseeing technical documentation and quality systems for medical devices. Her work includes verifying compliance of documentation with regulatory requirements, creating and improving quality management systems in accordance with ISO 13485 and ISO 9001, and conducting training on medical device regulations and quality system implementation. She has over 13 years of experience in quality management systems within the medical and food industries, including 9 years in the medical device sector — particularly in higher-class non-active devices, implantable products, and advanced wound dressings. Between 2014 and 2022, she served as Management Representative for Quality, Safety, and Medical Device Registration. She graduated from the University of Łódź, Faculty of Biology and Environmental Protection, specializing in microbiology, and completed postgraduate studies at the Lodz University of Technology, Faculty of Organization and Management, in Quality Management and Quality Systems.