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PubMed · 14515712

Risk management.

Grace Bartoo
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Abstract

All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.

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Device ApprovalEquipment DesignEquipment Failure AnalysisEquipment and SuppliesProduct Surveillance, PostmarketingProportional Hazards ModelsRisk FactorsRisk ManagementUnited StatesJournal Article

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Grace Bartoo. Risk management.. https://doi.org/10.1109/memb.2003.1237528

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