GHTF/IMDRF: The Pre-Market Model
Course Description:
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.
Watch the Course Trailer:
Learning Objectives:
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
Who Should Enroll:
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.
Prerequisite Knowledge/Requirements:
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.