Course Description

ISO 14155 GCP for Medical Device Studies – Main Differences with ICH 6

Course Description:

This short course will walk you through the various GCP regulatory documents applied in different parts of the world, starting with an introduction to ISO 14155. We'll cover the key differences between drug studies and medical devices. You will learn what is considered a medical device in its broadest definition and how devices are subject to risk classification. Based on the risks, you will see that there are essential steps to take before use in humans. Finally, we will cover in depth the definitions and processes specific to safety for clinical studies of medical devices.

Learning Objectives:

Identify key differences between ISO 14155 and drug trials.

Who Should Enroll:

Anyone willing to work with Medical devices and medical software: CRAs, medical staff, and project managers.

Prerequisite Knowledge/Requirements:

Previous knowledge of ICH GCP E6 (R2)

Subject Matter Expert:
Danielle Giroud

45 min

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Premium Account: € 113.00

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