100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Device RAC Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed $9.67   Add to cart

Exam (elaborations)

Device RAC Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed

 12 views  0 purchase
  • Course
  • Device RAC
  • Institution
  • Device RAC

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...

[Show more]

Preview 4 out of 65  pages

  • September 25, 2024
  • 65
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • Device RAC
  • Device RAC
avatar-seller
SterlingScores
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


4

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 $9.67. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

72042 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$9.67
  • (0)
  Add to cart