The course introduces students to the field of medical devices. It outlines the process for obtaining authorization to market a medical device, including a discussion on the current challenges for innovative research, medical device classification, international and local guidelines and regulations regarding the devices’ approval, and the conduct of associated clinical studies required for regulatory approval.
In addition, the course outlines clinical research involving medical devices and regulations for the safety monitoring and reporting of medical devices.
Learning Points:
- Medical Device Regulations and Classifications
- Medical Device Licensing and Quality Standards
- Comparison of US and International Standards of Medical Device Licensing
- Classification of Medical Devices in the USA
- FDA Regulations- Medical Devices/Licensing
- Premarket Approval (PMA)
- Quality Management System / ISO