I think these 9 design controls are necessary as a good checklist to ensure the project proceeds smoothly. While I don’t work in a medical device company, we follow a similar structure where I work. I’m part of the design and review aspect of the 9 design controls. Once the part is designed and reviewed, we order a sample in order to do fitment checks and verify that the product does what the customer had asked us to do. Sometimes we will send it out to customers to validate that it meets their needs and is how it’s supposed to be. We also order additional quantities of the part once, the initial sample is reviewed to see if manufacturing can meet our tolerance range. We have a documentation team that keeps track of and records design changes and the project history. So even though medical device companies required to use Design controls, I think it beneficial for other companies in different industries to also use these guidelines/controls.