Design Inputs are the key for medical device development. This is basically how a company can build its foundation on a certain product. In my view, design input is the start up of a device. This device must be approved of all it’s design inputs, meaning all its designs and manufacturing process must be acsepted first. Any medical device, must be examined thoroughly and making sure it can be functional and it performs according to its functions. Also, safety requirements are fulfilled. Once the Design Inputs are approved, design of the device may begin.

http://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm