Course Description

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. 

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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.

Subject Matter Expert:
Shelley Tang

30 min

Release date:

Related resources:

Case studies:

Peer review:
Martin de Bruin

Basic Account: € 89.00
Premium Account: € 66.00

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