Device RAC Exam Questions and
Answers | Latest Update | 2024/2025 |
Already Passed
What is the role of regulatory affairs professionals in the medical device industry?
A) To ensure compliance with regulations and guidelines
B) To create marketing strategies
C) To design medical devices
D...
Device RAC Exam Questions and
Answers | Latest Update | 2024/2025 |
Already Passed
What is the role of regulatory affairs professionals in the medical device industry?
✔✔A) To ensure compliance with regulations and guidelines
B) To create marketing strategies
C) To design medical devices
D) To conduct clinical trials
What does a De Novo classification request pertain to?
A) Devices that are already on the market
✔✔B) Devices that are novel and have no predicate
C) Devices undergoing recall
D) Devices in clinical trials
What is the purpose of a clinical evaluation report?
A) To market the device
✔✔B) To assess the clinical data supporting a device's safety and efficacy
1
,C) To provide customer testimonials
D) To outline financial projections
What type of documentation is essential for a design history file (DHF)?
A) Marketing materials
✔✔B) Records of the design and development process
C) Sales forecasts
D) Consumer feedback reports
What does the term "predicate device" mean?
A) A device that has been recalled
✔✔B) A legally marketed device to which a new device can be compared
C) A device currently in clinical trials
D) A device with expired approval
Which regulation outlines the requirements for reporting adverse events?
✔✔A) 21 CFR Part 803
B) ISO 9001
2
,C) 21 CFR Part 820
D) 21 CFR Part 11
What is the focus of a Risk Management Plan in medical devices?
A) Financial forecasting
B) Marketing strategies
✔✔C) Identifying and mitigating potential risks associated with a device
D) User feedback collection
What is the primary requirement for a Premarket Approval (PMA) application?
A) Proof of sales performance
✔✔B) Evidence of safety and effectiveness through clinical data
C) A marketing plan
D) User testimonials
What does the term "bench testing" refer to?
✔✔A) Laboratory testing to evaluate a device's performance
B) Testing in real-world scenarios
3
, C) Clinical testing with human subjects
D) Financial analysis of device costs
What is the significance of post-market clinical follow-up (PMCF)?
A) To evaluate sales strategies
✔✔B) To monitor long-term safety and performance of the device
C) To promote the device
D) To gather user opinions
What is the primary focus of the Medical Device Regulation (MDR) in the European Union?
A) To enhance marketing strategies
✔✔B) To ensure the safety and performance of medical devices throughout their lifecycle
C) To reduce manufacturing costs
D) To increase sales in the EU
Which document serves as a blueprint for the quality assurance processes of a medical device?
✔✔A) Quality Manual
B) Marketing Plan
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