Katarzyna Romaniszyn

Graduate of the University of Lodz, Department of Biology and Environmental Protection, specialization: microbiology and postgraduate studies at the Department of Organization and Management, Lodz University of Technology in the field of Management and Quality Management Systems. She has over 13 years of experience in Quality Management Systems in medical and food industry companies. For 8 years associated with the medical devices industry, in particular inactive devices of higher classes, implanted devices and specialist dressings. Between 2014 and 2022, she was the Management Board Representative for the Quality Management System, Safety and Registration of Medical Devices. She is responsible for managing a team of experts, developing a project execution strategy, organizational activities for consulting projects in the medical industry, verification of compliance of technical documentation with requirements for medical devices, verification and creation of ISO 13485, ISO 9001 Quality Management System documentation, and conducting training on medical devices and ISO 13485 Quality Management System.