RAC DEVICES EXAM QUESTIONS AND ANSWERS 100% ACCURATE
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RAC DEVICES
Institution
RAC DEVICES
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...
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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