Skip to main content
  • Training

ISO 14155: Clinical investigation of medical devices for human subjects

This course is intended to be an overview of Good Clinical Practices (GCPs) as outlined in ISO 14155 that is intended to be applied worldwide to clinical investigations of medical devices.

A laboratory worker sitting at a table reviews a guide


ISO 14155 is intended to regulate clinical investigations of medical devices as required by national, regional and international Health Authorities (HA). This course provides an overview of Good Clinical Practices (GCPs) as outlined in ISO 14155, including a summary of GCP principles, ethical considerations, Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB), informed consent and more. After completing this course, learners should be able to identify the specific requirements of ISO 14155 and identify ways to assess safety, clinical performance and effectiveness of investigational medical devices. 

icon of a clock


60 minutes

icon of a gear rotating


Clinical: Medical Device

icon of a book

Functional area

Clinical and Quality


ComplianceWire Online and Custom Content Brochure

810.34 KB

ComplianceWire Life Sciences eLearning Offerings

2.73 MB

Get connected with our sales team

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.

Please wait…