Development of a New Medical Device Production Line Using Systems Engineering
Pereira Williams, José E.
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Abstract - The design and development of a production line to manufacture a new medical device for clinical trials requires the establishment of a very precise implementation plan. This is especially important since we are dealing with products intended for human use subjected to the rigors of the Food and Drug Administration standards. The Systems Engineering methodology is a framework that can be used to manage complex systems and can be used successfully to bring together all the necessary areas or departments needed to complete a project on time. Following this methodology facilitates the generation of all the required documentation to make sure the production line effectively manufactures the intended product. This project combines the methodology of Systems Engineering with the Food and Drug Administration Quality System Regulations 21CFR Part 820. Key Terms - Clinical Trials, Complex Systems, Production Line, Systems Engineering