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. Further, as associated risk increases
the potential benefit to the patient must also increase.