It may be a longer process, depending on the category of your product. There are various legal reasons for becoming a corporation. There are different categories of incorporation, which determine the tax category of the company. A. Legal counsel is necessary for certain parts of the FDA approval process. An FDA consultant is another option.
Quality control is extremely important.
The manufacturing process is subcontracted, and there are specific controls for medical devices. A. Talk to people in the business. Talk to everyone you know. Its not about money, but that's one way to determine your success as a company. It is quite customary for a start-up company not to show a profit in the first 3 to 5 years.