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dc.contributor.advisorBruce C. Arntzen.en_US
dc.contributor.authorMedina, Melissa (Melissa M.)en_US
dc.contributor.otherMassachusetts Institute of Technology. Supply Chain Management Program.en_US
dc.date.accessioned2018-09-17T15:50:21Z
dc.date.available2018-09-17T15:50:21Z
dc.date.copyright2018en_US
dc.date.issued2018en_US
dc.identifier.urihttp://hdl.handle.net/1721.1/117928
dc.descriptionThesis: M. Eng. in Supply Chain Management, Massachusetts Institute of Technology, Supply Chain Management Program, 2018.en_US
dc.descriptionCataloged from PDF version of thesis.en_US
dc.descriptionIncludes bibliographical references (page 27).en_US
dc.description.abstractChanging regulatory requirements continues to be an increasingly complex issue in the medical device industry. Regulations place stress on regional supply chains across the world. Most recently, the European Parliament issued the Medical Device Regulation (EU) 2017/745 instituting new compliance framework for all devices manufactured, sold, and/or distributed in the European Union. The new framework requires the implementation of unique device identifiers and more stringent conformity assessment procedures. In addition, many device classification types have changed, post-market clinical surveillance has been instituted, and traceability through a centralized IT database is now mandated. While the the act aims to improve patient safety and efficacy across the medical device industry, it poses huge impacts across both the physical and informational flows in supply chains. This research evaluates the regulatory impact across supply chain operations using predictive modeling and machine learning. The model determines how various activities and events in manufacturing and sourcing environments contribute to supply constraints when modified to accommodate new regulatory requirements. The model also determines how product attributes contribute to performance variability. By taking a proactive approach to assess the impacts of regulatory changes, firms can optimize supply chain flows to reduce cost, lead-time, and service level risks.en_US
dc.description.statementofresponsibilityby Melissa Medina.en_US
dc.format.extent29 pagesen_US
dc.language.isoengen_US
dc.publisherMassachusetts Institute of Technologyen_US
dc.rightsMIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission.en_US
dc.rights.urihttp://dspace.mit.edu/handle/1721.1/7582en_US
dc.subjectSupply Chain Management Program.en_US
dc.titleModeling regulatory impacts on medical device supply chainsen_US
dc.typeThesisen_US
dc.description.degreeM. Eng. in Supply Chain Managementen_US
dc.contributor.departmentMassachusetts Institute of Technology. Supply Chain Management Program.en_US
dc.identifier.oclc1051223556en_US


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