RAC Sample Exam Questions and Answers | Latest Version | 2024/2025 | 100% Pass
8 views 0 purchase
Course
RAC Sample
Institution
RAC Sample
RAC Sample Exam Questions and
Answers | Latest Version | 2024/2025 |
100% Pass
What is the primary function of the International Organization for Standardization (ISO)?
A) To regulate pharmaceutical pricing
B) To develop and publish international standards
C) To conduct clinical trials
...
RAC Sample Exam Questions and
Answers | Latest Version | 2024/2025 |
100% Pass
What is the primary function of the International Organization for Standardization (ISO)?
A) To regulate pharmaceutical pricing
✔✔B) To develop and publish international standards
C) To conduct clinical trials
D) To market medical devices
Which regulatory body oversees the approval of medical devices in Europe?
A) FDA
✔✔B) European Medicines Agency (EMA)
C) Health Canada
D) World Health Organization (WHO)
What is the significance of the "CE" mark on a medical device?
✔✔A) Indicates conformity with European health and safety standards
B) Shows that the device is FDA approved
1
,C) Represents a warranty period
D) Demonstrates compliance with ISO 13485
What is a Design History File (DHF)?
A) A marketing strategy document
✔✔B) A compilation of records that describes the design and development of a device
C) A financial report
D) A user manual
What is required for a 510(k) submission regarding substantial equivalence?
A) Proof of unique technology
✔✔B) Evidence that the device is as safe and effective as a legally marketed device
C) A full clinical study
D) A financial impact analysis
What must a manufacturer do after a device has been recalled?
A) Increase marketing efforts
✔✔B) Investigate the cause of the recall and take corrective actions
2
,C) Reduce production levels
D) Notify competitors
What does the term "safety" mean in the context of medical devices?
A) The marketing strategy employed
✔✔B) The assurance that a device will not cause harm when used as intended
C) The device's effectiveness in treatment
D) The production efficiency of the device
What is a significant aspect of pre-market approval (PMA) submissions?
✔✔A) In-depth clinical evidence demonstrating safety and efficacy
B) A general overview of product features
C) Market demand analysis
D) Cost analysis
What does "design control" refer to in medical device development?
✔✔A) A systematic approach to ensure that the device meets user needs and regulatory
requirements
3
, B) Financial management during production
C) Marketing control measures
D) Post-market surveillance
What is the purpose of an Indications for Use statement in a regulatory submission?
A) To describe the manufacturing process
✔✔B) To specify the medical conditions the device is intended to treat or diagnose
C) To outline the pricing strategy
D) To define the target market
Which document outlines the procedures for handling product complaints?
A) Design control plan
✔✔B) Quality assurance manual
C) Marketing plan
D) Financial report
What does the term "adverse event reporting" entail?
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 $10.96. You're not tied to anything after your purchase.
