Medical device refers to any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings, for one or more of the specific purposes of: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, or alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy of a physiological process; supporting or sustaining life; preventin