Course Description

GHTF/IMDRF – Supporting Documents

Course Description:

This course provides an in depth review of the documents prepared by the GHTF/IMDRF which support the pre- and post-market regulatory models for medical devices. They also provide guidance for both manufacturers and regulatory agencies on quality management systems requirements, auditing and clinical evidence.

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Learning Objectives:

Upon completion of this course, trainees will have gained knowledge of the final pieces which comprise the GHTF/IMDRF model for regulating medical devices and support the major pillars of the international regulatory framework.

Who Should Enroll:

Regulatory affairs, quality assurance and clinical professionals in industry or regulators with an interest in the global market.

Prerequisite Knowledge/Requirements:
  • IDN 169 - Introduction to the Global Harmonization Task Force.
  • IDN 170 - GHTF/IMDRF – The Premarket Model.
  • IDN 171 - GHTF/IMDRF – The Post-market Model.

Knowledge of the European system for device regulation is also useful; however, this course can be considered as an introduction to it.

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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