Biomedical Devices Overview
Biomedical technology broadly refers to the application of engineering and technology principles to the domain of living or biological systems. Usually, the inclusion of the term biomedical denotes a principal emphasis on problems related to human health and diseases, whereas terms like “biotechnology” can be medical, environmental, or agricultural in the application. But most terms in this general realm still lack clear boundaries. Biomedical engineering and Biotechnology alike are often loosely called Biomedical Technology or Bioengineering. The Biomedical technology field is currently growing at a rapid pace. Required jobs for the industry expect to grow 23% by 2024.
Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, 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 medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices
- providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.