Device RAC - Study guides, Study notes & Summaries

Looking for the best study guides, study notes and summaries about Device RAC? On this page you'll find 270 study documents about Device RAC.

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Exam (elaborations)

DEVICE RAC FINAL EXAM SCRIPT 2026 QUESTIONS WITH ANSWERS FULLY REVIEWED
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55

January 2026

2025/2026

A+
DEVICE RAC FINAL EXAM SCRIPT 2026 QUESTIONS WITH ANSWERS FULLY REVIEWED
FocusFile7
R220,33 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS / ACTUAL TEST QUESTIONS WITH DETAILED VERIFIED ANSWERS / ALREADY GRADED A
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31

January 2026

2025/2026

A+
DEVICE RAC EXAM QUESTIONS / ACTUAL TEST QUESTIONS WITH DETAILED VERIFIED ANSWERS / ALREADY GRADED A
ScholarSync
R288,17 More Info

Exam (elaborations)

DEVICE RAC EXAM Questions and Answers 2026/2027 |Already Graded A+| Verified and Updated
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28

January 2026

2025/2026

A+
DEVICE RAC EXAM Questions and Answers 2026/2027 |Already Graded A+| Verified and Updated
Examchemist
R305,13 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS AND VERIFIED ANSWERS| A+ GRADED
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34

December 2025

2025/2026

A+
a comprehensive collection of Device RAC exam questions with verified correct answers, designed to closely reflect real regulatory affairs exam scenarios. It covers FDA medical device regulations, device classification, 510(k) pathways, PMA and HDE requirements, IDE regulations, Quality System Regulation (QSR), GMP compliance, MDR reporting, inspections, recalls, labeling, clinical investigations, and regulatory strategy, making it a thorough and exam-focused study resource for medical device re...
KelvinBrooks
R203,37 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS AND CORRECT ANSWERS
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28

December 2025

2025/2026

A+
a comprehensive collection of Device RAC exam questions with correct answers, designed to support preparation for medical device regulatory affairs certification. It covers FDA medical device regulations, 510(k) submissions, PMA and HDE pathways, IDE requirements, QSR and GMP compliance, MDR reporting, recalls and corrective actions, labeling, inspections, and regulatory strategy, making it a thorough and exam-focused study resource for regulatory professionals.
KelvinBrooks
R203,37 More Info

Exam (elaborations)

DEVICE RAC EXAM 2026 | Questions with 100% Correct Answers | Verified | Latest Update 2026| Graded A+
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31

December 2025

2025/2026

A+
DEVICE RAC EXAM 2026 | Questions with 100% Correct Answers | Verified | Latest Update 2026| Graded A+
ScholarSync
R288,17 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS With correct Answers (100% VERIFIED) Latest Update 2026/2027 | Graded A+.
Available in bundle

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14

December 2025

2025/2026

A+
Available in bundle
DEVICE RAC EXAM QUESTIONS With correct Answers (100% VERIFIED) Latest Update 2026/2027 | Graded A+. 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - ANSWER: B A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter...
ExcelAcademia2026
R271,21 More Info

Exam (elaborations)

Device Rac Exam Questions With 100% Correct Verified Answers | Latest Update 2026/2027 | Graded A+.
Available in bundle

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28

December 2025

2025/2026

A+
Available in bundle
Device Rac Exam Questions With 100% Correct Verified Answers | Latest Update 2026/2027 | Graded A+. A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Comparator device B. Predecessor device C. Predicate device D. Substantially equivalent device -correct-answer-C A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this techn...
ExcelAcademia2026
R271,21 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS AND ANSWERS | 100% SOLVED | LATEST UPDTAE 2026/2027 | VERIFIED.
Available in bundle

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29

December 2025

2025/2026

A+
Available in bundle
DEVICE RAC EXAM QUESTIONS AND ANSWERS | 100% SOLVED | LATEST UPDTAE 2026/2027 | VERIFIED. 1. If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation? A) Adulteration B) Improper Use C) Misbranding D) Idiocy - correct answer - A 2. Pre-market Notification Requirements would apply to a device that is: A) Substantially equivalent to a pre-amendment device B) Intended ...
ExcelAcademia2026
R271,21 More Info

Exam (elaborations)

DEVICE RAC EXAM QUESTIONS WITH VERIFIED ANSWERS LATEST UPDATE 2026/2027 (100% SOLVED)
Available in bundle

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71

December 2025

2025/2026

A+
Available in bundle
DEVICE RAC EXAM QUESTIONS WITH VERIFIED ANSWERS LATEST UPDATE 2026/2027 (100% SOLVED) Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Correct Answer - C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modificatio...
ExcelAcademia2026
R271,21 More Info