risk_management_in_corporate

May 20th, 2015
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Arkansas Tech University
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The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.

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ISO14971,2ndEd.,2007Medicaldevices:ApplicationofriskmanagementtomedicaldevicesByGrantSchmidbauerNemkoUSA,Inc.SanDiego,CAContentsIntroductiontoISO14971ScopeofISO14971KeytermsanddefinitionsGeneralrequirementsforriskmanagementRiskanalysisRiskevaluationRiskcontrolEvaluationofoverallresidualriskacceptabilityRiskmanagementreportProductionandpostproductioninformationSummaryIntroductiontoISO14971 TherequirementscontainedinthisInternationalStandardprovidemanufacturerswithaframeworkwithinwhichexperience,insightandjudgmentareappliedsystematicallytomanagetherisksassociatedwiththeuseofmedicaldevices.IntroductiontoISO14971 ThisInternationalStandardwasdevelopedspecificallyformedicaldeviceandmedicalsystemmanufacturersusingestablishedprinciplesofriskmanagement.IntroductiontoISO14971 ThisInternationalStandarddealswithprocessesformanagingrisks,primarilytothepatient,butalsototheoperator,otherpersons,otherequipmentandtheenvironment.IntroductiontoISO14971 Itisacceptedthattheconceptofriskhastwocomponents:a)theprobabilityofoccurrenceofharm;b)theconsequencesofthatharm,thatis,h

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