GHTF/IMDRF – The STED and Its Contents
This course takes a detailed look at the recommendations on the format and contents of the Summary Technical Documentation (STED) as developed by the Global Harmonization Task Force (GHTF) and now maintained under the International Medical Device Regulators’ Forum (IMDRF). We learn about the requirements for development of a STED, which contains the evidence that a medical device meets the Essential Principles for safety and performance, and receive guidance on what a manufacturer needs to include in the STED.
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Upon completion of this course, trainees will have gained an understanding of what documentation is required and how to develop a STED for submission to the regulatory authority.
Regulatory affairs and quality assurance 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.
An understanding of the GHTF model for regulation of medical devices.