Medical Devices and the FDA

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, …

…regulatory departments are needed just so the necessary paperwork can be generated for market approval. The FDA does recognize that through constant modification to the existing laws, and assisting the medical device industry in obtaining market approvals, together industry and government can work together to improve healthcare for the general public. Bibliography References 1. Marconi Medical Systems, Inc. MR GBC Work Instruction MR 313. 2. Duane Praschan, former Regulatory Affairs manager, Marconi Medical Systems. 3. http://www.fda.gov/