RAC Sample Exam Questions and Answers | Latest Version | 2024/2025 | 100% Pass
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RAC Sample
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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?
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