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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorGonzález Miranda, Carlos J.
dc.contributor.authorHernández Santiago, Adiel
dc.date.accessioned2024-10-16T18:49:43Z
dc.date.available2024-10-16T18:49:43Z
dc.date.issued2024
dc.identifier.citationHernández Santiago, A (2024). Design and Validation Strategy for Medical Device Product Transfer [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttps://hdl.handle.net/20.500.12475/2772
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractThe transfer of medical device products from development to manufacturing presents multifaceted challenges that demand meticulous planning and execution to ensure product quality, regulatory compliance, and cost-effectiveness. This article proposes an integrated approach leveraging principles of lean manufacturing and Six Sigma methodology to streamline the design and validation processes during product transfer. The application of lean manufacturing principles enables the identification and elimination of non-value-added activities, thus optimizing the transfer process for efficiency and resource utilization. Concurrently, Six Sigma methodology offers a structured framework for reducing variation and enhancing product quality through data-driven decision-making. This article outlines a comprehensive strategy encompassing key stages of product transfer, including design transfer planning, process validation, and risk management. Each stage is systematically analyzed and optimized to achieve seamless transition while meeting regulatory requirements and customer expectations. Key Term − Design validation, Lean manufacturing, Product transfer, Six Sigma.en_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2024;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Subject headings--Unassigneden_US
dc.titleDesign and Validation Strategy for Medical Device Product Transferen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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