Title: Module 1 Overview: Intro to Medical Device Quality Systems
Course: PW-Course-Import-Test > Section: Module 1: Introduction to Medical Device Quality Systems

Module 1

Watch

What do you know about the U.S. Food and Drug Administration (FDA)? Are you aware of what the FDA mission is?

You can read about the FDA's mission and watch the following video to see just one example of how the FDA is involved in potential mainstream public health and safety issues that may impact you today.

Not All Imported Products Sold as "Supplements" Are Safe

As you learned, part of the mission of the FDA is to establish quality requirements for food and drugs that are marketed in the USA. During this course you will learn about those quality requirements by studying the regulation 21 CFR 820, commonly referred to as the Quality System Regulation (QSR). This first module will introduce you to the history and different sections of the QSR.

Competency

After completing this module, you will be able to analyze the consequences related to CFR non-compliance of quality systems at a medical device company.

Learning Objectives

- Describe a quality system in the medical industry.
- Recognize the hierarchy of medical device enforcement structure.
- Summarize the cause and effect possibilities for enforcement actions.
- Research and identify the top areas of non-compliance and compliance risk.

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