DEVICE RAC EXAM || MOST RECENT EXAM 2026-2027
ACTUAL COMPLETE REAL EXAM QUESTIONS AND
CORRECT ANSWERS (VERIFIED ANSWERS) ALREADY
GRADED A+ | GUARANTEED SUCCESS!! | NEWEST
EXAM | JUST RELEASED!!
The Quality System Regulation (QSR) for medical devices
(21CFR 820)
pertains to the manufacturing of which of
the following:
A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished
devices -
ANSWER -C
The QSR for Class III devices applies to the following except:
A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in
the United States
,C) Research on investigational devices tested outside of the
United States
D) Contract Sterilizers - ANSWER -A
The QSR for medical devices (21CFR 820) requires all of the
following except:
A) Management to make a
commitment to quality
B) A Quality Plan that defines
how quality will be met
C) Management must review the
Quality System at least quarterly
D) A Quality representative must be
identified and documented - ANSWER -C
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 -
ANSWER -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 -
ANSWER -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
- ANSWER -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
ACTUAL COMPLETE REAL EXAM QUESTIONS AND
CORRECT ANSWERS (VERIFIED ANSWERS) ALREADY
GRADED A+ | GUARANTEED SUCCESS!! | NEWEST
EXAM | JUST RELEASED!!
The Quality System Regulation (QSR) for medical devices
(21CFR 820)
pertains to the manufacturing of which of
the following:
A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished
devices -
ANSWER -C
The QSR for Class III devices applies to the following except:
A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in
the United States
,C) Research on investigational devices tested outside of the
United States
D) Contract Sterilizers - ANSWER -A
The QSR for medical devices (21CFR 820) requires all of the
following except:
A) Management to make a
commitment to quality
B) A Quality Plan that defines
how quality will be met
C) Management must review the
Quality System at least quarterly
D) A Quality representative must be
identified and documented - ANSWER -C
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 -
ANSWER -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 -
ANSWER -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
- ANSWER -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
