- 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.
Medical Device Market Introduction