Do You Think the Fda Regulatory Process Is Good?

The fda doesn't tell you exactly how to set up your process. If you don't have any process at all, it's the wild west of medical devices. The challenge is that if you're not good at setting up your own process up front, you will create so much pain for yourself down the road. It's a bit of a chicken and egg because if you do change it, you need to requalify.