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What is a medical device? Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. Medical devices Dialysis machines Pacemakers Artificial limbs Artificial organs Cochlear implants Corrective lenses Dental implants Facial prosthetics Heart-lung machine Implants Infusion pumps Ocular prosthetics Somato prosthetics Medical imaging Electron microscopy Fluoroscopy Magnetic resonance imaging (MRI) Nuclear medicine Optical microscopy PET-CT scans Positron emission tomography (PET) Projection radiography such as X-rays and CT scans Tomography Ultrasound Subdisciplines of Biomedical Engineering Bioinformatics Bioinstrumentation Biomaterials Biomechanics BioMEMS/Microelectromechanical systems (MEMS) Biosignal Processing Biotechnology Cellular, Tissue, and Genetic Engineering Clinical Engineering Medical Imaging Microtechnology and Nanotechnology Neural Systems and Engineering Orthopedic Bioengineering Rehabilitation Engineering Robotics in Surgery Systems Physiology Regulatory issues |