Title: Module 2 Overview: Design Controls
Course: PW-Course-Import-Test > Section: Module 2: Design Controls

Module 2

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Why is medical device design important? Do you know of someone who regularly uses a medical device or has regular medical treatment that utilizes a medical device? Some common examples are CPAP machines for sleep disorders, dialysis treatment for renal disorder, and syringes for diabetes treatment. All of these treatments utilize medical devices that are controlled by 21 CFR 820.

Watch this short video to learn more about some of the reasons why the FDA has included a specific focus on Design Controls in the regulation.

1527_FDA Medical Device Regulation Design Control

The purpose of this module is to make you aware of the specific 21 CFR 820 requirements for Design Controls. This section of the regulation is relevant to anyone who desires to pursue a career that has involvement with medical device quality systems, but is particularly relevant to individuals that desire a career in traditional engineering fields (including software development and biomedical engineering) and who may wish to specialize in medical device design.

Competency

After completing this module, you will be able to explain the purpose of design controls with the medical device industry.

Learning Objectives

- Cite the reasons behind why design controls are part of regulation.
- Illustrate the Design Control lifecycle for a medical device.
- Describe the objectives of Design Verification and Design Validation and the differences between the two.
- Describe how a finished medical device design can be changed.

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