Lesson 1: History of Medical Devices and their regulatory framework
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After completing 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
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