Title: Design Controls for Medical Devices (Subpart C)
Course: PW-Course-Import-Test > Section: Module 2: Design Controls

Module 2

How do you take an innovative idea and “translate” it into a viable, safe, and effective Medical Device? The FDA regulations define the requirements for Design Controls.

What are design controls?

The Design Control process is intended to ensure that medical devices are safe and effective. Throughout the design development process and continuing throughout the product lifecycle, the medical device and all subsequent changes are reviewed to ensure that safety, efficacy, and intended performance remain satisfactory. In this module we will explore the requirements for Medical Device Design Controls (21 CFR 820.30).

Here is the Wikipedia definition for Medical Device Design Controls.

Watch

Watch this video for a brief overview of Design Controls.

Implementing Design control for Medical Devices and IVDs

Why are design controls required?

The design of a medical device product is critical with respect to function, safety, reliability, risk controls, etc. In fact, the importance of Design Controls is so significant that the FDA has published additional guidance on how to successfully implement a compliant system. This guidance reinforces the requirements of 21 CFR 820.30. The Design Controls Guidance should be consulted during the development of work processes related to Design Control. Although this is a somewhat lengthy document, reading it in it’s entirety is highly beneficial for individuals that are targeting engineering or quality system career paths in a medical device company and need to have a thorough understanding of all requirements.

Read

Read the Design Controls Guidance document to understand why design controls are important and to help prepare for participating in the Community of Learning discussion.