Introduction to Medical Devices and their regulatory framework

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