What the Thalidomide disaster did to the FDA was not only demonstrate the importance of drug trials, as Chris’s post pointed out, but, even more importantly, tightened surveillance on how these trials...

I disagree and feel your application is more than a simple mobile medical app, I would consider it a rehabilitation device (conveniently packaged as an app on your phone, ipad, etc.). (I am expanding ...

Combination product development alone is very tricky because of the FDA's rudimentary policies on combination products. Manufacturers are often left scratching their heads as to which regulatory pathw...

I think I might enjoy working in a classical functional organization. I like working in research/engineering and would prefer not to be bothered with the marketing, manufacturing, or accounting aspect...

For a Project Manager, the difficulty in hopping from fundamentally different projects would be in executing project planning. The inventory of necessary materials, equipment, and specialists, time ma...

Design Validation means exactly that, verifying that the right device was designed. For example, if a user wanted an ointment to heal burn scars but the final product only caused hair to grow on the s...