Mr. Shlomi Harpaz holds a M.Sc. and B.Sc. in biomedical engineering from the Technion, as well as an M.A. in general history. In his work as a regulatory and quality consultant at H.M.Da, Shlomi has been providing medical device companies with consultation throughout the product development process, and has helped companies define their regulatory routes and submit their product to the FDA and to Notified Bodies. Shlomi has worked with several companies that develop products (including stand-alone software products) that lie on the borderline between regulated and unregulated devices, as well as with several companies that develop new medical technologies that lie on the borderline between a de novo submission and a 510(k).