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RAC Study Guide PowerPoint Presentation
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RAC Study Guide

RAC Study Guide

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RAC Study Guide

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  1. Pass Regulatory Affairs Certification (RAC) Global Scope exam in just 24HOURS! 100% REAL EXAM QUESTIONSANSWERS Regulatory Affairs Certification (RAC) Global Scope Buy Complete Questions Answers Filefrom 100% Exam Passing Guarantee & Money BackAssurance

  2. SampleQuestions Question No1: 510(k. Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluationexcept: High FluxHemodialyzer Blood specimen collectiondevice Pistonsyringe Cardiopulmonary bypass bloodtubing Answer: B Question No2: The Quality System Regulation (QSR. for medical devices) (21CFR 820. pertains to the manufacturing of which of the following)? Finished devices, but notaccessories Finished devices and components of finisheddevices Finished devices and accessories to finisheddevices Finished devices, components, and accessories to finisheddevices Answer: C Question No3: The Quality System Regulation for Class III devices applies to the following except? Critical componentmanufacturers Operations done by the manufacturer at facilities located in the United States Research on investigational devices tested outside of the UnitedStates ContractSterilizers Answer:A

  3. Question No4: The Quality System Regulation (QSR. for medical devices (21CFR 820. requires all of the followingexcept? Management to make a commitment toquality A Quality Plan that defines how quality will bemet Management must review the Quality System at leastquarterly A Quality representative must be identified anddocumented Answer: C Question No5: The Quality System Regulation (QSR. for medical devices regarding Design Controls require which of thefollowing)? Documentation of early research of thedesign Design and development plans address how design inputs and requirements aremanaged A product design can be outsourced by a manufacturer so they do not have to maintain thedocumentation Design activities are only required for Class III Investigationaldevices Answer: B Question No6: Design Control "verification" requires which of thefollowing? The product design meets the usersneeds The process produces a product that meets predeterminedspecifications The product design meets specified requirements The product design meets the intended use requirements Answer:C

  4. Question No7: According to the QSR, Design Inputs are best described by thefollowing? The Operator's Manual and instructions on how to use thedevice The Instructions for Use (IFU. of thedevice Marketing claims and features that are required for thedevice The performance requirements that the product mustmeet Answer: D Question No8: According to the QSR, Design Outputs contain thefollowing? The Device Master Record(DMR. The documentation from the last phase of the complete Design Control process The test reports that support that the Design Inputs have beenmet All of the packaging and labeling associated with the finisheddevice A and Dabove Answer: E Question No9: According to the QSR, Quality Audits must accomplish thefollowing? Meet the same requirements of the originalGMP Evaluate if the Quality System is in compliance with theQSR Determine the effectiveness of the QualitySystem Focus on Design Controls and the CAPAsystem B and Cabove A and Dabove Answer: B, C,E

  5. Question No10: • According to the QSR, personnel involved in the design, manufacture, distribution, servicing, and reportingmust? • Must hold a Master's degree orhigher • At a minimum receive procedure training once per year in their area of responsibility • Be able to recite the Quality Policy, ifasked • Be made aware of defects which may occur if they do not perform their job correctly • Answer:D • Buy Complete Questions Answers Filefrom • PDF Version + Test Engine SoftwareVersion • 90 Days Free UpdatesService • Valid for AllCountries