Medical Devices and the FDA essays

Medical Devices and the FDA essays Marconi Medical Systems Magnetic Resonance division designs, manufactures, and installs MRI systems and associated equipment for the worldwide medical diagnostic imaging market. In addition, Marconi MR imports MRI systems from Nordstar (located in Helsinki, Finland) and installs them in the United States. Associated equipment includes surface coils and physician viewing stations. Surface coils are specialized transducers, which, when used with an MRI machine, produce high-quality images of specific portions of the anatomy. MR designs, manufactures, and installs surface coils as well. Marconi Medical Systems as a whole, is a transnational corporation. While retaining its strength in the United Stated, MRs products have achieved global recognition. Strengths in markets such as Europe and South America have opened doors to Asian countries such as Japan and China. MR has a variety of customers, but focuses primarily on hospitals and imaging centers. MR customers expect high quality systems that are easy to use, have low operating cost, high throughput, and can support new technology. An MR system must provide superior image quality and offer a range of imaging techniques to support diagnosis. Given the high cost of the equipment ($900,000 on average), customers expect smoothly installed, easy to operate, reliable, low maintenance equipment that provides a solid return on investment. To make all this possible, Marconi must pass the Food and Drug Administrations (FDA) stringent policies and procedures for the safe and effective use of a medical device. Unlike x-ray based medical diagnostic techniques such as computed tomography, magnetic resonance imaging (MRI) and spectroscopy are techniques that do not employ ionizing radiation. As such, it is considered to be less hazardous than other x-ray imaging techniques. In addition, since x-rays can only discriminate different tissues by electron density, which does not vary greatly...