Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.

The requirement for medical device companies to use design controls is established in 21 CFR Part 820, as well as ISO 13485:2016.

The classic design control “waterfall” diagram looks like this:

At a high level, the idea behind design controls is that they will not only improve the design of a device as the team goes through design and development, but also help to prevent future issues with a device once it’s placed on the market.

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