Title: The Design Control Process
Course: PW-Course-Import-Test > Section: Module 2: Design Controls

Module 2

In the preceding section, we explored the requirements of the regulation. During this section we will take a deeper look at the Design Control process with respect to how it actually applies in the “real” world.

If you are someone who has never worked in a medical device environment, your first exposure to the entire Design Control process can be overwhelming. We will step through the process and cover some of the key design control “intersections” in this section.

What do Design Controls/Design Development Processes “look” like in the real world?

Read

Review this example of a highly detailed medical device development process in Mapping the Medical Device Development Process to gain a greater understanding of how an overarching Design Control process looks in real life.

The process flow charts starting on Page 20 offer excellent visualization of a detailed and complex Design Control process.