GHTF/IMDRF: The Pre-Market Model
This course follows ID N169: “Introduction to the GHTF or IMDRF” and describes in further detail the GHTF/IMDRF recommendations for a pre-market regulatory model for medical devices. It provides an overview of the elements of the pre-market system and how they fit within the overall regulatory system for medical devices.
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Upon successfully completing this course, trainees will be able to:
- Understand the elements which comprise the GHTF/IMDRF pre-market system
- Apply these components to demonstrate the safety and performance of medical devices
Regulatory affair, quality assurance, and clinical professionals in the industry, and regulators with an interest in the global market are all encouraged to enroll in this course.
The following course is required:
- Introduction to the GHTF or IMDRF (ID N169)
Additionally, knowledge of the European system for device regulation is useful but not required.