You would also need approval in the EU and in other countries around the world. There are many standards that medical devices must meet. It takes a pretty good

You would also need approval in the EU and in other countries around the world. There are many standards that medical devices must meet. It takes a pretty good sized company to do all things that must be done in order to actually design, manufacture, ship, surveil, maintain and end-of-life a medical device of any complexity.