Course Description

GHTF/IMDRF: Summary Technical Documentation (STED) and Its Contents

Course Description:

This course provides a detailed look at recommendations for the format and content of Summary Technical Documentation (STED). These guidelines were developed by the Global Harmonization Task Force (GHTF) and are now maintained under the International Medical Device Regulatory Forum (IMDRF). 

This course also illustrates the specific requirements for developing STEDs, one of which is evidence that a medical device meet the essential principles for safety and performance. It also provides guidance on what manufacturers must include in STEDs.

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Learning Objectives:

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

  • Gain an understanding of what documentation is required for developing STEDs
  • Develop an STED for submission to the appropriate regulatory authority

Who Should Enroll:

Regulatory affairs and quality assurance professionals with an interest in the global market, manufacturers seeking to access markets in countries using the GHTF model, and regulators involved in developing and implementing regulatory systems for medical devices are all encouraged to participate in this course.

Prerequisite Knowledge/Requirements:

An understanding of the GHTF model for regulation of medical devices is required for this course.

Subject Matter Expert:
Shelley Tang

50 min

Related resources:

Case studies:

Basic Account: € 148.00
Premium Account: € 111.00

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