must have these

Your business must solve these requirement.

Venture capital firms do not fund medical device inventions -  unless - a seasoned CEO from a related industry comes on board.

To make matters more selective, most deals in healthcare relate to medical services; few deals are for innovative medical devices!

These funds are usually advanced in limited increments by accounting oriented  people based on achieving certain milestone accomplishments. The risks to this plan are potentially your development becomes “the donkey chasing a carrot” You will have to defend technical achievements to earn the next funding increment.

In most cases, accountants will manage venture capital development the accountants they will only disperse funds based on milestone.

Your device or engineering system must solve these FDA requirement.

The Food & Drug Administration process is straightforward, providing you have followed good science. For a Class II you must establish:

·        the device is safe {failure modes and their effects},

·        the device is effective {established by a performance to standards},

·        the device has benefited from engineering design controls,

·        the device performs to specific requirements throughout its life cycle.

·        the device is substantially equivalent, properly labeled and indications for use.