ISO 14155:2020 – A Summary Review
Course Description:
This course provides a condensed yet inclusive summary review of the latest version of the ISO 14155 standard.
It covers the following topics:
- When to apply ISO 14155 requirements
- The basics of ethics requirements
- Essential tasks and elements needed during the preparation, conduct, and closing of clinical investigations
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Understand the general requirements of ISO 14155 as a good clinical practice guidance (specifically for medical device clinical investigations)
- Apply ISO 14155 requirements to ethics committee or institutional review board processes internationally
- Identify the requirements of the informed consent process
- Determine the planning needed before, during, and at the termination of a clinical investigation
Who Should Enroll:
Clinical and quality assurance professionals involved in clinical data and regulatory professionals involved in clinical investigations for medical devices are all welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.