Five Steps to Bring a Medical Device to Market

Published: Aug. 23, 2022, 3:10 p.m.

So - you're a hot new startup with a snappy new medical device. \n\nNow what? \n\nDo you have an intended use statement? Do you have the \U0001d633\U0001d62a\U0001d628\U0001d629\U0001d635 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?\n\nThere are a lot of potholes along the road to market clearance or approval, so come along with me as I explain what you need to avoid derailing your go-to-market plans.