In this course you will be able to:
- Understand key definitions of Medical Devices and in vitro diagnostics (IVDs)
- Acquire knowledge about the regulatory framework of the Medical Devices and in vitro diagnostics (IVDs)
- Follow the history of the Medical Devices and the regulatory framework
- Understand the key principles for application of the Medical Devices
- Describe the classifications of the Medical Devices and in vitro diagnostics (IVDs)
- Understand the role of the Notified Body and Conformity assessment
- Acquire knowledge about CE marking and re-certification