Medical Devices

A medical device is any device intended for medical purposes. The use of a device for medical purposes harbors a significant risk potential. Therefore, medical devices must be shown to be safe and effective with reasonable assurance before regulators allow the device to be sold in their country.

In general, as the risk associated with a product increases, so does the number of tests required to demonstrate its safety and effectiveness. In addition, the associated risk also increases the potential benefit for the patient.