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RAC Devices Exam NEWEST VERSION WITH COMPLETE
450 QUESTIONS AND CORRECT VERIFIED ANSWERS
WITH RATIONALES LATEST UPDATE JUST RELEASED THIS
YEAR
Ensuring a medical device meets defined user needs and intended use is accomplished
through which type of validation?
A. Design,
B. Device,
C. Process,
D. Product
A. Design
Design validation ensures that a medical device meets the defined user needs and intended
use. It involves testing and evaluations to confirm that the device's final design outputs meet
the input requirements, including functionality, safety, and performance in real-world
conditions. This validation typically includes user testing, clinical trials, or simulated use
environments to verify the device meets its intended purpose.
According to FDA, "remanufacturing" is the processing, conditioning, renovating, repackaging,
restoring, or any other act done to a finished device that significantly changes which of the
following?
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A. The performance/safety specification, or intended use of the finished device,
B. The intended use or fundamental technology of the device,
C. The performance safety specification or operating,
D. The labeling and or packaging of the finished device
A. The performance/safety specification, or intended use of the finished device.
According to the FDA, remanufacturing refers to activities that significantly alter a finished
device's performance, safety specifications, or intended use. These changes go beyond simple
refurbishing or servicing and affect the core characteristics of the device, which could impact its
regulatory classification or necessitate new submissions to the FDA.
Cybersecurity is a responsibility of which of the following:
A. Device manufacturers and healthcare providers.,
B. Device manufacturers, healthcare providers, and ,
C. Regulators and vulnerability finders.,
D. All stakeholders
D. All Stakeholders
Cybersecurity is a shared responsibility involving all stakeholders, including device
manufacturers, healthcare providers, regulators, and those who identify vulnerabilities. Each
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group plays a critical role in ensuring the security of medical devices throughout their lifecycle
by addressing potential risks, implementing safeguards, and responding to emerging threats.
Which of the following represent cybersecurity information needed for a 510(k) submission?
A. Objective evidence of manufacturer participation,
B. A list and justification for all cybersecurity
C. Device instructions for use and product specific,
D. B and C
D. B and C
For a 510(k) submission, cybersecurity information should include:
B. A list and justification for all cybersecurity controls: This includes a description of the
cybersecurity measures implemented in the device and the rationale for those measures.
C. Device instructions for use and product-specific cybersecurity information: This includes
details provided to users about how to maintain cybersecurity, such as recommendations for
password management, software updates, and other device-specific instructions.
These elements help ensure that the device's cybersecurity risks are adequately addressed and
managed.
Your company manufactures a patient scale that sometimes fails testing during a certain stage
of production. When this happens, the product is inspected, repaired, and retested by a
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technician in the servicing department, and then returned to production for further
manufacturing. There exists only a small number of causes for failure at this stage, and the
repair solutions are simple and fast. In order to help ensure compliance of this activity with
ISO 13485, which of the following MUST bein place?
A. Training of the servicing technician on all manufacturing,
B. Annual internal audit of this activity to ensure,
C. Documented procedures that describe the inspection, repair and retesting activities.
D. A and B
C. Documented Procedures that describe the inspection, repair, and retesting activities.
Under ISO 13485, to ensure compliance, it is essential to have documented procedures that
clearly describe how the inspection, repair, and retesting processes are conducted. These
procedures help ensure that the activities are consistently performed and controlled, providing
traceability and accountability throughout the manufacturing process. While training and
internal audits are important, the priority for compliance in this scenario is the documentation
of the procedures for these specific activities.
Prior to initiating a clinical trial, the company discovers that the non-clinical study results
were incorrectly documented. Which of the following is the MOST appropriate course of
action for the company?
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SUCCESS!
RAC Devices Exam NEWEST VERSION WITH COMPLETE
450 QUESTIONS AND CORRECT VERIFIED ANSWERS
WITH RATIONALES LATEST UPDATE JUST RELEASED THIS
YEAR
Ensuring a medical device meets defined user needs and intended use is accomplished
through which type of validation?
A. Design,
B. Device,
C. Process,
D. Product
A. Design
Design validation ensures that a medical device meets the defined user needs and intended
use. It involves testing and evaluations to confirm that the device's final design outputs meet
the input requirements, including functionality, safety, and performance in real-world
conditions. This validation typically includes user testing, clinical trials, or simulated use
environments to verify the device meets its intended purpose.
According to FDA, "remanufacturing" is the processing, conditioning, renovating, repackaging,
restoring, or any other act done to a finished device that significantly changes which of the
following?
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A. The performance/safety specification, or intended use of the finished device,
B. The intended use or fundamental technology of the device,
C. The performance safety specification or operating,
D. The labeling and or packaging of the finished device
A. The performance/safety specification, or intended use of the finished device.
According to the FDA, remanufacturing refers to activities that significantly alter a finished
device's performance, safety specifications, or intended use. These changes go beyond simple
refurbishing or servicing and affect the core characteristics of the device, which could impact its
regulatory classification or necessitate new submissions to the FDA.
Cybersecurity is a responsibility of which of the following:
A. Device manufacturers and healthcare providers.,
B. Device manufacturers, healthcare providers, and ,
C. Regulators and vulnerability finders.,
D. All stakeholders
D. All Stakeholders
Cybersecurity is a shared responsibility involving all stakeholders, including device
manufacturers, healthcare providers, regulators, and those who identify vulnerabilities. Each
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group plays a critical role in ensuring the security of medical devices throughout their lifecycle
by addressing potential risks, implementing safeguards, and responding to emerging threats.
Which of the following represent cybersecurity information needed for a 510(k) submission?
A. Objective evidence of manufacturer participation,
B. A list and justification for all cybersecurity
C. Device instructions for use and product specific,
D. B and C
D. B and C
For a 510(k) submission, cybersecurity information should include:
B. A list and justification for all cybersecurity controls: This includes a description of the
cybersecurity measures implemented in the device and the rationale for those measures.
C. Device instructions for use and product-specific cybersecurity information: This includes
details provided to users about how to maintain cybersecurity, such as recommendations for
password management, software updates, and other device-specific instructions.
These elements help ensure that the device's cybersecurity risks are adequately addressed and
managed.
Your company manufactures a patient scale that sometimes fails testing during a certain stage
of production. When this happens, the product is inspected, repaired, and retested by a
3
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technician in the servicing department, and then returned to production for further
manufacturing. There exists only a small number of causes for failure at this stage, and the
repair solutions are simple and fast. In order to help ensure compliance of this activity with
ISO 13485, which of the following MUST bein place?
A. Training of the servicing technician on all manufacturing,
B. Annual internal audit of this activity to ensure,
C. Documented procedures that describe the inspection, repair and retesting activities.
D. A and B
C. Documented Procedures that describe the inspection, repair, and retesting activities.
Under ISO 13485, to ensure compliance, it is essential to have documented procedures that
clearly describe how the inspection, repair, and retesting processes are conducted. These
procedures help ensure that the activities are consistently performed and controlled, providing
traceability and accountability throughout the manufacturing process. While training and
internal audits are important, the priority for compliance in this scenario is the documentation
of the procedures for these specific activities.
Prior to initiating a clinical trial, the company discovers that the non-clinical study results
were incorrectly documented. Which of the following is the MOST appropriate course of
action for the company?
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