The creation of any tools that will be used in the diagnosis of patients is known as Medical Device Manufacturing. An equipment can only be termed as medical equipment if it can perform the function of diagnosing sickness and at the same time help in the treatment of the patient. Similarly, the device should not, in any case, interfere with the chemical or natural metabolism of the patient for it to fall under the description of medical device. The CT scanners, x-ray machines and any other tool which is not a drug, are among the notable medical devices. No standards are in place requiring the makers of the medical devices to follow. 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.
The medical devices are usually grouped into three categories depending on the type of service they offer to the patients. That equipment which is not meant to provide any life-supporting service to the patient is categorized into group one. Similarly, this equipment should not be able to prevent instances of human impairment that may be facing the patient. Any a form of harm that faces the patients should however not be generated by the use of these medical devices. The the second group of the medical devices is made up of machines which are commonly referred to as the general controls and the special control 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. In order to prevent the condition of the patient from deteriorating, these machines can be used. The greater threat that is associated with the devices under the general control and special group makes them necessitate for permission for one to be allowed to use them.
The third class of the medical devices involves the general controls and premarket approval devices. The handling of devices that are found in this group brings along further threats. For any individual or organization to be permitted to use the devices in this class, they should seek the approval of the relevant body mandated to oversee the use of these devices in their countries. The marketing of the products in this segment should also involve the seeking of prior permission from higher authority in the medical field. 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.