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RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+$0.00
RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
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Course
RAC DEVICES
Institution
RAC DEVICES
RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
1. Which of the following is a primary reg- C) Food and Drug Administration
ulatory body for medical devices in the
United States?
A) European Medicines Agency (EMA)
B) Medicines and Healthcare products
Regulatory Agency (MHRA)
C) Food and Drug Administration (FDA)
D) Therapeutic Goods Administration
(TGA)
2. What is the purpose of a 510(k) submis- B) To demonstrate that a device
sion? is substantially equivalent to a
A) To obtain premarket approval for a legally marketed device
high-risk device
B) To demonstrate that a device is sub-
stantially equivalent to a legally market-
ed device
C) To apply for a CE mark for European
market entry
D) To report adverse events related to a
device
3. Which of the following is true about ISO C) It specifies requirements for a
13485? quality management system spe-
A) It is a standard for environmental cific to medical devices
management systems
B) It provides guidelines for clinical trial
design
C) It specifies requirements for a quality
management system specific to med-
ical devices
D) It is a regulatory submission process
for high-risk devices
4. What is required for a device to obtain C) Demonstration of conformity
CE marking? with EU regulatory requirements
A) Approval from the FDA
B) A premarket notification (510(k))
C) Demonstration of conformity with EU
, RAC Devices Exam
regulatory requirements
D) Submission of a clinical evaluation
report to the FDA
5. Which risk management process in- B) Risk Analysis
volves identifying potential hazards as-
sociated with a medical device?
A) Risk Control
B) Risk Analysis
C) Risk Assessment
D) Risk Mitigation
6. Describe the difference between a Class I devices are considered
Class I and a Class III medical device. low risk and typically require gen-
Provide examples of each. eral controls (e.g., bandages).
Class III devices are high risk and
require premarket approval (e.g.,
pacemakers).
7. What are the key components of a De- Key components of a DMR in-
vice Master Record (DMR)? clude: production specifications,
production process specifica-
tions, quality assurance proce-
dures, and packaging and label-
ing requirements
8. Explain the significance of post-mar- Post-marketing surveillance in-
ket surveillance in regulatory affairs for volves monitoring the device's
medical devices. performance and safety after it is
on the market, including tracking
adverse events and implement-
ing corrective actions (as need-
ed).
9. Outline the steps involved in prepar- Steps involved in a PMA applica-
ing a premarket approval (PMA) appli- tion include:
cation. - pre-submission meetings with
the FDA
- preparation of the PMA applica-
tion (including clinical data)
, RAC Devices Exam
-submission of the application
-FDA review
-potential approval with condi-
tions
10. What is the role of an Institutional Re- An IRB reviews and approves
view Board (IRB) in clinical trials for clinical trial protocols to ensure
medical devices? ethical standards and participant
safety are maintained.
11. A medical device company is preparing For the U.S. market: 510(k) sub-
to launch a new infusion pump in the mission or PMA depending on
U.S. and European markets. The com- the risk classification.
pany is seeking regulatory approval in
both regions. For the European market: CE
marking submission with a Noti-
Identify the regulatory submissions re- fied Body.
quired for the U.S. market and the Euro-
pean market.
12. A medical device company is preparing For the U.S. market, 510(k) or
to launch a new infusion pump in the PMA documentation includes:
U.S. and European markets. The com- -device description
pany is seeking regulatory approval in -intended use
both regions. -substantial equivalence
-clinical data
Discuss the key considerations and -manufacturing information.
documentation needed for each sub-
mission type. For the European market, CE
marking documentation includes:
-technical file
-clinical evaluation
-risk management file
-conformity assessment.
13. A medical device company is preparing Post-market surveillance should
to launch a new infusion pump in the include:
U.S. and European markets. The com- -routine monitoring of device per-
pany is seeking regulatory approval in formance
both regions. -collection of adverse event re-
, RAC Devices Exam
ports
Explain how the company should ap- -implementation of corrective ac-
proach post-market surveillance and tions
reporting for both markets.
Both markets require regular re-
porting of adverse events and up-
dates to regulatory bodies.
14. A medical device company is preparing Challenges include differences
to launch a new infusion pump in the in regulatory requirements and
U.S. and European markets. The com- timelines. Solutions may involve
pany is seeking regulatory approval in consulting with regulatory ex-
both regions. perts in each region and ensur-
ing thorough and simultaneous
Consider the potential challenges the preparation of submission docu-
company might face in meeting reg- ments.
ulatory requirements in both regions
and suggest solutions to address these
challenges.
15. A medical device company is preparing Risk management involves:
to launch a new infusion pump in the -identifying potential hazards
U.S. and European markets. The com- -assessing risks
pany is seeking regulatory approval in -implementing controls to miti-
both regions. gate those risks throughout the
device lifecycle, ensuring safety
Describe the role of risk management in and compliance
ensuring compliance and safety of the
infusion pump.
16. Which class of medical device general- C) Class III
ly requires the most stringent regulato-
ry controls? Class III medical devices gen-
A) Class I erally require the most stringent
B) Class II regulatory controls. These de-
C) Class III vices are considered high-risk
D) Class IV and typically require premarket
approval (PMA) from the FDA,
which involves extensive clinical
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