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RAC COMPLETE Medical Devices 2024 - BUNDLED Exams. Graded A
RAC COMPLETE Medical Devices 2024 - BUNDLED Exams. Graded A
[Show more]RAC COMPLETE Medical Devices 2024 - BUNDLED Exams. Graded A
[Show more]RAC Exam practice Exam 2024 with complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) 
Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable 
poisonous substances(1:1) - A: Proof o...
Preview 2 out of 14 pages
Add to cartRAC Exam practice Exam 2024 with complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) 
Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable 
poisonous substances(1:1) - A: Proof o...
RAC Practice Exam 1 Latest 2024 with complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and 
electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and 
actions that create,...
Preview 3 out of 17 pages
Add to cartRAC Practice Exam 1 Latest 2024 with complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and 
electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and 
actions that create,...
DEVICE RAC EXAM QUESTIONS AND ANSWERS 
2024 WITH COMPLETE SOLUTION 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary 
mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - C 
A company wants to modify its legally marketed device such that the mo...
Preview 3 out of 18 pages
Add to cartDEVICE RAC EXAM QUESTIONS AND ANSWERS 
2024 WITH COMPLETE SOLUTION 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary 
mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - C 
A company wants to modify its legally marketed device such that the mo...
US RAC Review Questions RAPS Modules 2024 with 
complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a 
new ind...
Preview 3 out of 24 pages
Add to cartUS RAC Review Questions RAPS Modules 2024 with 
complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a 
new ind...
DEVICE RAC 2024 Questions and Answers Graded 
A(Actual test) 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary 
mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - C 
A company wants to modify its legally marketed device such that the modifica...
Preview 3 out of 18 pages
Add to cartDEVICE RAC 2024 Questions and Answers Graded 
A(Actual test) 
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary 
mode of action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP - C 
A company wants to modify its legally marketed device such that the modifica...
RAC Devices Exam Prep 2024 Questions and Answers 
Correct 
Who is the European Medicines Agency (EMA) - an agency of the European Union (EU) in charge 
of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to 
harmonise the work being done by the indivi...
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Add to cartRAC Devices Exam Prep 2024 Questions and Answers 
Correct 
Who is the European Medicines Agency (EMA) - an agency of the European Union (EU) in charge 
of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to 
harmonise the work being done by the indivi...
RAC (Device) Exam Prep 2024 
A manufacturer sells 1,500 medical devices in the two months following launch. A user, but not a 
patient, is seriously injured while using the medical device. The investigation reveals the cause to be an 
error in a software subroutine that has a one in 195,000 chance o...
Preview 1 out of 3 pages
Add to cartRAC (Device) Exam Prep 2024 
A manufacturer sells 1,500 medical devices in the two months following launch. A user, but not a 
patient, is seriously injured while using the medical device. The investigation reveals the cause to be an 
error in a software subroutine that has a one in 195,000 chance o...
RAC Exam New Edition 2024 Solved Correctly 
drug - Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of 
disease in man. 
medical device - An instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent or similar or relate article, includ...
Preview 3 out of 18 pages
Add to cartRAC Exam New Edition 2024 Solved Correctly 
drug - Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of 
disease in man. 
medical device - An instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent or similar or relate article, includ...
RAC Exam Prep - EU MDD/AIMDD & MDR 2024 with 
complete solution;(Study Aid - RAC) 
Similar but more detailed than the Essential Requirements - General Safety and Performance 
Requirements 
This ISO standard includes the most recent update to specific medical device companies quality 
management syst...
Preview 2 out of 9 pages
Add to cartRAC Exam Prep - EU MDD/AIMDD & MDR 2024 with 
complete solution;(Study Aid - RAC) 
Similar but more detailed than the Essential Requirements - General Safety and Performance 
Requirements 
This ISO standard includes the most recent update to specific medical device companies quality 
management syst...
RAC Exam practice test bank 2024 all possible questions 
and answers with complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) 
Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidabl...
Preview 2 out of 14 pages
Add to cartRAC Exam practice test bank 2024 all possible questions 
and answers with complete solution 
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) 
Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidabl...
RAC Practice Exam 1 Questions and Answers New Version 
2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and 
electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and 
action...
Preview 3 out of 17 pages
Add to cartRAC Practice Exam 1 Questions and Answers New Version 
2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and 
electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries and 
action...
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