A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases
Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. Items as intricate as housings for cochlear implants are manufactured through the deep drawn and shallow drawn manufacturing processes. The design of medical devices constitutes a major segment of the field of biomedical engineering.