General Biomedical Devices Manufacturers

Bio medical device is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. It is also intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.The devices include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics and dental implants.Bio Medical devices can be regulated and classified as class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and post market surveillance. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes. Class III devices require premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.