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dc.contributor.advisorGiardina, Steve Ph.D.
dc.contributor.advisorSmith, Oney Ph.D.
dc.contributor.advisorSteele, David D.V.M.
dc.contributor.authorBorek, Mary Lisa
dc.contributor.departmentGraduate Schoolen_US
dc.contributor.programMaster of Science in Biomedical Scienceen_US
dc.date.accessioned2019-04-01T19:43:54Z
dc.date.available2019-04-01T19:43:54Z
dc.date.issued2019-01
dc.descriptionResearch to develop a 510(k) checklist/inventory of steps based on the phases of development for a Class II medical device working towards a 510(k) submission to the FDA. The 510(k) Inventory Tool was developed to be an effective tool to consistently identify important regulatory deliverables, refine regulatory direction, and ensure that technical requirements are adequately addressed during medical device development. The final 510(k) Inventory Tool is available from the author upon request.en_US
dc.description.abstractDesigning and developing medical devices is a complex undertaking with significant opportunities, dependencies, and risks for the stakeholders. This capstone project explores the concept of developing a tool for the regulatory professional with a goal of improving both the quality of regulatory engagement in medical device development and product development efficiency, specifically in cases where the 510(k) FDA regulatory approval process is being used. This is accomplished by creating a checklist tool, the 510(k) Inventory Tool, utilizing published data about known 510(k) submission deficiencies and post-market device reports, then integrating these checklists into appropriate points in the medical device development process, leveraging traditional phase gate project methodologies. By exercising the 510(k) Inventory Tool within the medical device development process, the regulatory affairs professional would have a checklist tool to facilitate project team engagement, to generate stage-appropriate regulatory discussion, and to develop measured strategies for project risk mitigation during the development lifecycle.en_US
dc.format.extent64 pagesen_US
dc.genreField Work Projecten_US
dc.identifierdoi:10.13016/m2fqbs-7nb2
dc.identifier.urihttp://hdl.handle.net/11603/13291
dc.language.isoen_USen_US
dc.relation.isAvailableAtHood College
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subjectRegulatory Affairsen_US
dc.subjectMedical Device Developmenten_US
dc.subject510(k)en_US
dc.subjectFDAen_US
dc.subjectFood and Drug Administrationen_US
dc.titleThe 510(k) Inventory Tool: A Regulatory Tool For Use In Medical Device Developmenten_US
dc.typeTexten_US


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Attribution-NonCommercial-NoDerivs 3.0 United States
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivs 3.0 United States