Скачать или смотреть Regulatory Pathways to Clearance: Transitioning University Discoveries

1. Defining your medical device
2. Intended use vs Indication
3. Types of device market approval applications/pathways
4. Regulatory Pathway Assessments
5. Other submissions
6. Meeting with the regulators

Dr. Julie Cramer serves as the Associate Director of Clinical and Regulatory Affairs of the Pittsburgh-based company, Clinical Research Strategies (CRS). During this talk, Julie will provide a regulatory perspective on how to transition your device-based discoveries out of the University. She will discuss topics such as how to define your medical device, differences between your device's intended use and indication, types of device market approval applications/pathways and Regulatory Pathway Assessments.