A medical device is: any instrument, apparatus, appliance, software, material or other article that is used alone or in combination, including software specifically for diagnostic or therapeutic purposes, that the manufacturer intends for use in human beings. Such devices are used for:
Diagnosis, prevention, monitoring, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap
Investigation, replacement, or modification of the anatomy or of a physiological process
Control of conception (EU definition)
Design and manufacture of medical devices require highly inter-disciplinary technologies that combine clinical medicine, electro-mechanics, electronics, mechanical engineering, and optical science.
