- Important dates in the transition period
- Topics that will help you determine strategy during the transition
- What you should know about products that will survive in accordance with MDR (MDR 2017/745/EU) rules
- Topics that will change with MDR
- Medical Device description
- Classification
- New relationships with Certification Bodies
- Safety and Performance Requirements
- Conformity Assessment Route Selection
- Creating technical documentation for Medical Device
- Importance of quality management system in Medical Device Regulation
- Risk Management Process
- Clinical Data Evaluation
- Clinical Research Requirement
- Mandatory activities required post-market (PMS &PMCF & Recall)
- Economic Operators
- EUDAMED
- UDI
- Roadmap for ensuring MDR compliance
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.
