Clinical Investigation & MDR

  • What is Clinical Trial? Why is Clinical Trial important?
  • What are the important terminologies used in Clinical Trials?
  • Types of Clinical Trials in Medical Devices
  • Key differences in Drug and Medical Device Clinical Trials
  • How is the number of patients to be involved in the Clinical Trial determined?
  • MDR effects and reflection in Clinical Trial
  • How should PMCF be planned? What are the expectations of MEDDEV and MDR?


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.