So - you're a hot new startup with a snappy new medical device.

Now what?

Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What about your predicate device?

There 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.