RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass
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Course
RAC Practice
Institution
RAC Practice
RAC Practice Exam Questions and
Answers | Latest Update | 2024/2025 |
100% Pass
What is the primary purpose of regulatory affairs?
A) To ensure product marketing strategies are effective
B) To ensure compliance with laws and regulations in healthcare
C) To manage sales and distribution
...
RAC Practice Exam Questions and
Answers | Latest Update | 2024/2025 |
100% Pass
What is the primary purpose of regulatory affairs?
A) To ensure product marketing strategies are effective
✔✔B) To ensure compliance with laws and regulations in healthcare
C) To manage sales and distribution
D) To enhance customer service practices
Which of the following is a common requirement for premarket approval of medical devices?
A) Completion of an annual report
✔✔B) Submission of clinical data demonstrating safety and efficacy
C) Consumer surveys
D) Market analysis
What does the term "biocompatibility" refer to in medical devices?
✔✔A) The ability of a material to perform with an appropriate host response
B) The cost-effectiveness of the device
1
, C) The ease of manufacturing the device
D) The longevity of the device
What is one key role of the FDA in drug regulation?
A) Setting prices for pharmaceutical products
✔✔B) Evaluating new drugs for safety and effectiveness before approval
C) Conducting marketing research
D) Developing advertising strategies for drugs
Which class of medical device generally requires the most regulatory scrutiny?
A) Class I
B) Class II
✔✔C) Class III
D) Class IV
What does "Good Manufacturing Practice" (GMP) ensure?
✔✔A) That products are consistently produced and controlled according to quality standards
B) That marketing materials are accurate
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