The creation of any tools that will be used in the diagnosis of patients is known as Medical Device Manufacturing. A material that can help in the diagnostic of any ailment in an individualor aid in the recovery process of the person can, therefore, be termed as a medical equipment. Also, for the equipment to be considered as a medical device, it should not be able to tamper with the normal body functioning of a person. The mostly known medical devices are the CT scanners, the x-ray machines and any other form of medical aid which is not a drug. There are no set standards which require the various medical equipment to be made with. However, the various medical regulatory bodies have a system of guidelines that requires the manufacturing firms to adhere to produce medical; equipment which is of a good standard.
Three classes of the medical devices exist, arising from the need to group them according to the type of service they will give to the parents. The devices in group one comprise of medical devices which are not supposed to offer any life-supporting services to the patients. Also, the devices in this class should not be able to prevent a person from becoming impaired. The equipment, however, should not pose any risk of causing harm or injury to the patients. The devices commonly referred to as general controls, and special controls form the second group of the medical devices. Due to the role the machines in this stage play in helping in sustaining the life of an individual, they are therefore known to be very crucial. These devices can be at the same time used in preventive acts to avoid the condition of the patient from worsening. The general and special controls group poses some risks and therefore relevant permission ought to be granted from those in authority before a person is permitted to use them.
The medical devices that fall in the third class group are those which are known as the general controls and premarket approval devices. The devices in this category are at an even higher risk regarding handling. For accompany or individual to be permitted to use these kinds of devices, they have to seek permission from the relevant medical regulatory bodies in their country. In order for one to engage in promotional services for the devices in this category, he should also be able to seek for the approval from those in authority in the medical industry. The life of an individual can be made better and at the same time severely threatened by the use of medical devices in this category.