Therefore, medical devices must be shown to be safe and effective with reasonable guarantees before regulatory governments allow the device to be placed on the market in their country.
Generally, as the risk associated with the device increases, the amount of testing required to establish safety and efficacy also increases. Furthermore, as the associated risk increases, so must the potential benefit to the patient.
The medical devices vary in both their intended use and their indications for use. Examples range from simple, low-risk devices such as tongue depressors, clinical thermometers, disposable gloves, and urinals, to complex, high-risk devices that are implanted and life-sustaining.
An example of high-risk devices is that have built-in software, such as pacemakers, and that help perform medical tests, implants, and prostheses. Medical device design is an important segment of the field of biomedical engineering.
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