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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.
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.
An understanding of the GHTF model for regulation of medical devices is required for this course. Subject Matter Expert: Shelley Tang. WMDO provides you with the extensive knowledge and unrivaled experience of the medical device industry's leading experts and authorities to deliver the latest and most effective online medical device training available in the world. My Cart Login. Course Description.
Course title:. Course Description:. Learning Objectives:. Who Should Enroll:. Add to cart. Download course PDF. About WMDO. All rights reserved.
What is the STED format for medical device technical documentation?
IMDRF or still GHTF for STED and other guidance?