RAC Sample Test Questions and Answers | Latest Version | 2024/2025 | Already Passed
8 views 0 purchase
Course
RAC Sample
Institution
RAC Sample
RAC Sample Test Questions and
Answers | Latest Version | 2024/2025 |
Already Passed
What is the main focus of risk management in medical device development?
A) To identify, assess, and mitigate potential hazards associated with the device
B) To enhance product marketing strategies
C) To i...
RAC Sample Test Questions and
Answers | Latest Version | 2024/2025 |
Already Passed
What is the main focus of risk management in medical device development?
✔✔A) To identify, assess, and mitigate potential hazards associated with the device
B) To enhance product marketing strategies
C) To increase production speed
D) To evaluate sales performance
In the context of medical devices, what does the term "predicate device" refer to?
A) A device that is no longer in use
B) A device that has been withdrawn from the market
✔✔C) A legally marketed device to which a new device is compared for substantial equivalence
D) A device that is undergoing clinical trials
Which of the following is a key component of the FDA's Quality System Regulation (QSR)?
A) Enhanced customer service
B) Reduced production costs
1
,✔✔C) Establishing a framework for the manufacturing process to ensure consistent quality
D) Increasing the number of marketing strategies
What is one of the primary objectives of human factors engineering in device design?
A) To ensure aesthetic appeal
✔✔B) To enhance usability and minimize user error
C) To maximize production efficiency
D) To reduce regulatory compliance
What does the term "biocompatibility" refer to in medical devices?
A) The device's marketing potential
B) The device's ability to function in various environments
✔✔C) The device's ability to perform without causing adverse reactions in the body
D) The device's durability over time
When is a medical device considered "adulterated" under the Federal Food, Drug, and Cosmetic
Act?
✔✔A) If it fails to meet quality standards or is manufactured under unsanitary conditions
2
,B) If it is overproduced
C) If it is not properly marketed
D) If it has not been sold for a certain period
What is a key requirement for submitting a De Novo request to the FDA?
✔✔A) Providing evidence that the device is low to moderate risk and not substantially
equivalent to any existing device
B) Proving that the device has already been marketed
C) Demonstrating that the device can be manufactured at a lower cost
D) Showing that the device has been successfully used in Europe
Which of the following activities is critical during the design validation phase of a medical
device?
✔✔A) Conducting clinical evaluations to verify that the device meets user needs and intended
uses
B) Finalizing marketing strategies
C) Reducing manufacturing time
D) Developing financial projections
3
, What does the term "labeling" encompass for a medical device?
A) Only the packaging design
B) Marketing materials and advertisements
✔✔C) Instructions for use, safety warnings, and promotional claims about the device
D) Only the product description
What is the purpose of the FDA’s Investigational Device Exemption (IDE)?
A) To speed up the approval process for all medical devices
✔✔B) To allow a device to be used in clinical trials without pre-market approval
C) To ensure all devices undergo public scrutiny
D) To eliminate the need for post-market surveillance
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labeling specifications
C. Design reviews
D. Calibration records ✔✔B. Labeling specifications
4
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller SterlingScores. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $10.98. You're not tied to anything after your purchase.
