If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally making things into a bigger deal than they really need to be.

That being said, there are some areas that I’d like to address to help medical device engineers navigate their way more easily through design controls requirements. Let’s take a look:

1. Don’t believe the misconceptions

Probably the biggest misconception about design controls is that they equal a heavy load of burdensome documentation. People who believe this also often believe statements like: “Following good design controls will only slow down our product development” and, “Design controls will stifle innovation in our business.”

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