Medical device

Any equipment meant to be used for medical reasons is considered a medical device. Since utilizing a device for medical purposes carries a significant risk, medical devices must be demonstrated to be safe and effective with a high degree of confidence before regulatory bodies permit the device to be marketed in their nation. Generally speaking, the more testing needed to prove a gadget's safety and efficacy, the higher the associated risk of the device. Furthermore, the patient's potential benefit must rise in tandem with the related risk.