What does a medical device company produce

Production of medical devices. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software; whose utility is obtained primarily by physical and other means, not by pharmacological, immunological, or metabolic means, or which, although involved in these means, play only a supplementary role; and whose purpose is:

(i) the diagnosis, prevention, monitoring, treatment, or alleviation of disease;

(ii) the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury;

(iii) the testing, substitution, modulation, or support of physiological structures or physiological processes;

(iv) the support or maintenance of life;

(v) the control of pregnancy;

(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.

Medical devices themselves are subdivided into Class I, Class II, and Class III.