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RAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATE

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RAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATERAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATERAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATERAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATEANSWERS 100% ACCURATE A company is performing routine site monitoring of its pivotal cli...

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  • September 29, 2024
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  • RAC DEVICES
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RAC DEVICES EXAM QUESTIONS

AND ANSWERS 100% ACCURATE


A company is performing routine site monitoring of its pivotal clinical study

for a blood sugar meter and finds one site has not consented one-third of its

subjects properly . What is the FIRST thing the company needs to do?




A.Stop the entire study

B. Inform FDA and ask for guidance

C. Re-train the study staff, including the principle investigator

D. Re-consent all improperly consented subjects - ANSWER-D Re-consent all

improperly consented subjects




You are tasked with helping develop a regulatory intelligence procedure for

continuously collecting and analyzing regulatory information pertaining to

chromosome enumeration probes (CEPs), a type of in vitro diagnostic (IVD)

device. Which of the following inputs should be considered when creating

this procedure?

,A. Sources of content (for example - blogs and white papers)

B. Identification of applicable government publications

C. Databases containing international standards and,

D. All options listed above should be considered. - ANSWER-D. All options

listed above should be considered.




Ensuring a medical device meets defined user needs and intended use is

accomplished through which type of validation?




0 Design, 1 Device, 2 Process, 3 Product - ANSWER-Design




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?




0 The performance/safety specification, or intended use of the finished

device,

1 The intended use or fundamental technology of the device,

2 The performance safety specification or operating,

, 3 The labeling and or packaging of the finished device - ANSWER-The

performance/safety specification, or intended use of the finished device.




Cybersecurity is a responsibility of which of the following:




0 Device manufacturers and healthcare providers.,

1 Device manufacturers, healthcare providers, and ,

2 Regulators and vulnerability finders.,

3 All stakeholders - ANSWER-All Stakeholders




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,

C. Device instructions for use and product specific,

B and C - ANSWER-B and C




Your company manufactures a patient scale that sometimes fails testing

during a certain stage of production. When this happens, the product is

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