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DEVICE RAC EXAM QUESTIONS (ACTUAL) 2024 QUESTIONS AND ANSWERS
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DEVICE RAC EXAM QUESTIONS (ACTUAL) 2024 QUESTIONS AND ANSWERS
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DEVICE RAC EXAM QUESTIONS(ACTUAL)
The QSR for medical devices regarding Design Controls require which of the
following:
A) Documentation of early research of the design
B) Design and development plans address how design inputs and requirements
are managed
C) A product design can be outsourced by a manufacturer so they do not have to
maintain the documentation
D) Design activities are only required for Class III Investigational devices -
ANSWERS-B
Design Control "verification" requires which of the following:
A) The product design meets the users needs
B) The process produces a product that meets predetermined specifications
C) The product design meets specified requirements
D) The product design meets the intended use requirements - ANSWERS-C
,According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
D) The performance requirements that the product must meet - ANSWERS-D
According to the QSR, Design Outputs contain the following:
A) The Device Master Record (DMR)
B) The documentation from the last phase of the complete Design Control process
C) The test reports that support that the Design Inputs have been met
D) All of the packaging and labeling associated with the finished device
E) A and D above - ANSWERS-E
According to the QSR, Quality Audits must accomplish the following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
, F) A and D above - ANSWERS-E
According to the QSR, personnel involved in the design, manufacture,
distribution, servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their area of
responsibility
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not perform their job
correctly - ANSWERS-D
According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
D) All of the above - ANSWERS-D
Which division would have primary jurisdiction over a vascular graft with an
antibiotic based on primary mode of action?
A. CDER
B. CBER
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