- *Requirements of IEC 62366-1: 2015 and similar standards
- What is usability?
- Usage error and patient risk
- User profile and usage environment for usability
- Usability test design
Lecturers
Özlem ÖZEN; after graduating from Anadolu University, Department of Materials Science and Engineering, completed her master's degree at Augsburg University, Faculty of Physics, Department of Materials Science. In the medical device sector, she has been working as a consultant at AdviQual with her experience in Quality Management systems, CE Certification processes, Risk Management and Regulation.
She provides solutions tailored to customer expectations for obtaining European (CE) and USA (FDA) approvals from the design process of the medical device and subsequently improving the quality management systems.
As an AdviQual Consultant; she experienced in respiratory circuits, medical devices containing animal and human tissue derivatives, wound care products, hemostats, orthopaedic, spinal implants, dental devices (implant, bridge, expander), active medical devices (reverse osmosis for hemodialysis systems, phototherapy systems, patient heating systems, baby care incubators, rehabilitative robot systems), disinfect, cleaning solutions and medical devices used as software along with various IVD groups.
She provides solutions tailored to customer expectations for obtaining European (CE) and USA (FDA) approvals from the design process of the medical device and subsequently improving the quality management systems.
As an AdviQual Consultant; she experienced in respiratory circuits, medical devices containing animal and human tissue derivatives, wound care products, hemostats, orthopaedic, spinal implants, dental devices (implant, bridge, expander), active medical devices (reverse osmosis for hemodialysis systems, phototherapy systems, patient heating systems, baby care incubators, rehabilitative robot systems), disinfect, cleaning solutions and medical devices used as software along with various IVD groups.
