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Prominent biomedical engineering applications include the development of biocompatibleprostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro- implants, common imaging equipment such as MRIs and EEGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biologicals. Bioinformatics. As an interdisciplinary field of science, bioinformatics combines computer science, statistics, mathematics, and engineering to analyze and interpret biological data. Bioinformatics is both an umbrella term for the body of biological studies that use computer programming as part of their methodology, as well as a reference to specific analysis . Common uses of bioinformatics include the identification of candidate genes and nucleotides (SNPs). Often, such identification is made with the aim of better understanding the genetic basis of disease, unique adaptations, desirable properties (esp. 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Some examples include the improvement of crop technology (not a medical application, but see biological systems engineering), the manufacture of synthetic human insulin through the use of modified bacteria, the manufacture of erythropoietin in hamster ovary cells, and the production of new types of experimental mice such as the oncomouse (cancer mouse) for research. Neural engineering. Neural engineers are uniquely qualified to solve design problems at the interface of living neural tissue and non- living constructs. Pharmaceutical engineering. It may be deemed as a part of pharmacy due to its focus on the use of technology on chemical agents in providing better medicinal treatment. The ISPE is an international body that certifies this now rapidly emerging interdisciplinary science. Medical devices. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in the research and development of new devices for innovative therapies. 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 postmarket 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 generally require premarket approval (PMA) or premarket notification (5. Class I. Examples include replacement heart valves, hip and knee joint implants, silicone gel- filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra- bone) implants. Medical imaging. This area deals with enabling clinicians to directly or indirectly . This can involve utilizing ultrasound, magnetism, UV, radiology, and other means. Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including: fluoroscopy, magnetic resonance imaging (MRI), nuclear medicine, positron emission tomography (PET), PET- CT scans, projection radiography such as X- rays and CT scans, tomography, ultrasound, optical microscopy, and electron microscopy. Implants. The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional. In some cases, implants contain electronics, e. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug- eluting stents. Bionics. Concerned with the intricate and thorough study of the properties and function of human body systems, bionics may be applied to solve some engineering problems. Careful study of the different functions and processes of the eyes, ears, and other organs paved the way for improved cameras, television, radio transmitters and receivers, and many other useful tools. These developments have indeed made our lives better, but the best contribution that bionics has made is in the field of biomedical engineering (the building of useful replacements for various parts of the human body). Modern hospitals now have available spare parts to replace body parts badly damaged by injury or disease . Biomedical engineers work hand in hand with doctors to build these artificial body parts. Clinical engineering. Major roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs), selecting technological products/services and logistically managing their implementation, working with governmental regulators on inspections/audits, and serving as technological consultants for other hospital staff (e. Clinical engineers also advise and collaborate with medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state of the art so as to redirect procurement patterns accordingly. Their inherent focus on practical implementation of technology has tended to keep them oriented more towards incremental- level redesigns and reconfigurations, as opposed to revolutionary research & development or ideas that would be many years from clinical adoption; however, there is a growing effort to expand this time- horizon over which clinical engineers can influence the trajectory of biomedical innovation. In their various roles, they form a . 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Protective measures have to be introduced on the devices to reduce residual risks at acceptable level if compared with the benefit derived from the use of it. A product is effective if it performs as specified by the manufacturer in the intended use. Effectiveness is achieved through clinical evaluation, compliance to performance standards or demonstrations of substantial equivalence with an already marketed device. The previous features have to be ensured for all the manufactured items of the medical device. This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle. The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. 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