Course Description

GHTF/IMDRF – The Post-Market Model

Course Description:

This course follows ID N170: “The Pre-Market Model” and further delves into the GHTF/IMDRF recommendations for a post-market regulatory model for medical devices. It provides a description of post-market roles and responsibilities and elaborates on the necessary activities and requirements for adverse event reporting. 

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Understand the components of the GHTF/IMDRF post-market system
  • Determine what actions are required for adverse event reporting

Who Should Enroll:

Regulatory affair, quality assurance, and clinical professionals in the industry, and regulators with an interest in the global market are all welcome to enroll in this course.


Prerequisite Knowledge/Requirements:

The following courses are required:

  • Introduction to the GHTF or IMDRF (ID N169)
  • GHTF/IMDRF: The Pre-Market Model (ID N170)

Additionally, knowledge of the European system for device regulation is useful but not required.


Subject Matter Expert:
Shelley Tang

Duration:
30 min

Release date:
10/30/2012

Related resources:
Yes

Case studies:
No

Peer review:
Martin de Bruin

Price:
Basic Account: € 89.00
Premium Account: € 66.00

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