Product Risk Classifications

Overview of how products are classified based on their Risk level

Product Risk Classifications

Lesson 1: Welcome

About this course

In this course we discuss how products are classified by the FDA and notified bodies.

In this course we will review:

  • How products are classified
  • Various product classifications
  • How to determine your product's risk classification

At the end of the course, complete the course quiz for your records.


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() lessons in this course

Class I Devices (Low Risk)
Class II Devices (Moderate Risk)
Class III Devices (High Risk)


Welcome to the Product Risk Classifications course!

This course is an overview of how to classify your product based on its level of risk. We also discuss the type of rigors and controls required by the FDA and notified bodies.

Let's get started!

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