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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Lizardo, Ángel E.
dc.contributor.authorPereira Williams, José E.
dc.date.accessioned2020-10-28T11:28:00Z
dc.date.available2020-10-28T11:28:00Z
dc.date.issued2012
dc.identifier.citationPereira Williams, J. E. (2012). Development of a new medical device production line using systems engineering [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/914
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractAbstract - 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 Engineeringen_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesFall-2012;
dc.relation.haspartSan Juanen_US
dc.subject.lcshMedical instruments and apparatus industry--Managementen_US
dc.subject.lcshAssembly-line methodsen_US
dc.subject.lcshSystems engineeringen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleDevelopment of a New Medical Device Production Line Using Systems Engineeringen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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