Course Description

ISO 14155: 2011 – A Summary Review

Course Description:

This course provides a condensed yet inclusive summary review of the ISO 14155 2011 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
  • Brief explanation of the main responsibilities of sponsors and investigators

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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
  • Grasp the general the responsibilities of sponsors and investigators

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.

Subject Matter Expert:
Danielle Giroud

44 min

Release date:

Related resources:

Case studies:

Basic Account: € 134.00
Premium Account: € 100.00

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