Cli̇ni̇cal Evaluati̇on & Mdr - Trainings | Quality, Regulatory, Clinical consultancy

CER

What is Clinical Evaluation?
What are the sources of the documents and data used in clinical evaluation?
Data generated by literature review
Data generated by clinical experience
Data generated as a result of clinical trial
Clinical data appraisal ()
Analysis of clinical data
Writing the clinical evaluation report
Risk/Benefit Analysis and Evaluation of Total Residual Risk

PMS

What is Post-Market Surveillance?
Post-Market Surveillance MDR Requirements
Post-Market Surveillance Recommendations and Methods
Recall and Vigilance process
PMS Standard
PMS process
PMS activities

PSUR

Reporting Requirements for Post-Market Surveillance within the scope of MDR
Vigilance Management
Vigilance Management within the scope of MDD
Changes that come with MDR for Vigilance

PMCF

Post-Market Clinical Follow-up (PMCF)
What is Post-Market Clinical Follow-up?
Post-Market Clinical Follow-up Requirements as per MDR
Post-Market Clinical Follow-up Methods
Post-Market Clinical Follow-up Reporting Requirements within the scope of MDR

SSCP

Lecturers

Pınar Nebol has been working in Medical Device Research & Development, Clinical Research for more than 15 years. She graduated from Izmir Institute of Technology (Chemical Engineering) and completed her master degree at New Jersey Institute of Technology in the department of Biomedical Engineering with a Fullbright Scholarship.

Post-graduation, Pınar Nebol has been studying with bioresorbable polymers and drug combinations and has taken in various roles in a company manufacturing Medical Devices used in interventional cardiology and interventional radiology. Since 2015, Pınar Nebol has been a consulting on clinical studies and clinical evaluation of the Medical Devices and she is the co-founder of DeSia Clinical Research.

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.

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.

Trainings