Course Description

GHTF/IMDRF – Essential Principles of Safety and Performance for Medical Devices

Course Description:

This course takes a detailed look at the Essential Principles for safety and performance of medical devices, as developed by the Global Harmonization Task Force (GHTF) and now maintained under the International Medical Device Regulators’ Forum (IMDRF).  We explain the intent of each Essential Principle and provide guidance on how a manufacturer should demonstrate compliance.

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Learning Objectives:

Upon completion of this course, trainees will have gained an understanding of what the Essential Principles are, what they mean and what is involved in demonstrating compliance.

Who Should Enroll:

Regulatory affairs professionals with an interest in the global market, manufacturers who wish to access markets in countries which have adopted the GHTF model, regulators involved in developing and implementing regulatory systems for medical devices

Prerequisite Knowledge/Requirements:

An understanding of the GHTF model for regulation of medical devices

Subject Matter Expert:
Shelley Tang

83 min

Related resources:

Case studies:

Basic Account: € 245.00
Premium Account: € 184.00

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