- IVDR Philosophy
- Economic Operators and Responsibilities for IVDR
- Responsibilities of IVDR Manufacturers
- IVDR Product Classification
- Selection of The Conformity Assessment Route
- General Safety and Performance Requirements
- Technical Documentation
- The importance of product claims
- Labeling, UDI, EUDAMED
- Performance Evaluation
- Clinical Data
- Post-Market Surveillance and Updates
Lecturers
Başak Baranoğlu has started her career in 1999, after successfully completing a BS degree in Biology from METU and MBA from Bilkent University in 1999, and now is an accomplished veteran in the field of Quality Management Systems for Medical Devices.
After holding various senior management positions at Bıçakcılar and Alvimedica, she established AdviQual with a goal to provide consultancy and technical training in the field of quality management in particular to Medical Devices.
She leads the company with her team of accomplished quality management consultants to provide end-to-end solutions to medical device manufacturers and works in collaboration with foreign experts and AdviQual's international partners.
After holding various senior management positions at Bıçakcılar and Alvimedica, she established AdviQual with a goal to provide consultancy and technical training in the field of quality management in particular to Medical Devices.
She leads the company with her team of accomplished quality management consultants to provide end-to-end solutions to medical device manufacturers and works in collaboration with foreign experts and AdviQual's international partners.
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.
