Rac device exam prep 2024 Study guides, Class notes & Summaries
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RAC Prep Medical Devices Study Guide Exam Questions 2024.
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RAC Prep Medical Devices Study Guide Exam Questions 2024. 
device - CORRECT ANSWER instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for primary purpo...
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RAC Devices Exam Prep-US High Risk 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+
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RAC Devices Exam Prep-US High Risk 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ 
Number of Days for review of PMA - 180 days 
How many routes to a PMA? - 3 Routes: 
1. 
2 
3 
What makes a PMA unique (vs 510k)? - -Must include section on clinical investigations on human subjects 
-Must include a seperate volume on QS for review by CDRH/OC (office of compliance) 
-Includes a premarket QMS inspection 
-Sponsor should update the PMA periodically during review (if...
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RAC Exam Prep - EU MDD/AIMDD & MDR 2024 with complete solution;(Study Aid - RAC)
- Exam (elaborations) • 9 pages • 2024
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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 system? - 13485:2016 
Which entity affixes it's identification number near the CE Mark? - Notified Body, if involved in 
the conformity assessment 
Un-classified devices not requiring CE mark - Custom-ma...
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RAC Exam Prep 2024 - International Regulatory | 157 Questions and Answers Verified by Expert
- Exam (elaborations) • 16 pages • 2023
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RAC Exam Prep 2024 - International Regulatory | 157 Questions and Answers Verified by Expert
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RAC Prep Medical Devices Exam Prep (2023 – 2024) With Complete Solution
- Exam (elaborations) • 11 pages • 2023
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RAC Prep Medical Devices Exam Prep (2023 – 2024) With Complete Solution
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RAC Prep Medical Devices Exam Prep 2024 with complete solution
- Exam (elaborations) • 16 pages • 2024
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RAC Prep Medical Devices Exam Prep 
2024 with complete solution 
device - Answer ️️ -instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent or related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment 
or prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for prima...
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RAC Prep Medical Devices Exam Updated 2024 Graded A+
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RAC Prep Medical Devices Exam Updated 
2024 Graded A+ 
device - ANSinstrument, apparatus, implement, machine, contrivance, implant, 
in vitro reagent or related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, 
mitigation, treatment or prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for primary purpose 
Exempt dev...
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RAC Prep Medical Devices Exam Prep 2024 with complete solution
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RAC Prep Medical Devices Exam Prep 2024 with complete 
solution 
device - instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or 
related article: 
-recognized by NF-USP 
-intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or 
prevention of disease 
-intended to affect the structure or function of the body 
-not achieving any primary purpose through chemical action 
-not dependent on metabolism for primary purpose 
Exe...
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US RAC Exam Prep 2024 | 175 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+
- Exam (elaborations) • 44 pages • 2024
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US RAC Exam Prep 2024 | 175 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ 
30-day hold - (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 
120-day Safety Report - Amendment to an NDA conta...
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RAC (Device) Exam Prep 2024
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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 of happening. Management is 
concerned about how the incident may result in serious problems in the marketplace. What 
recommendation is MOST appropriate for the regulatory professional to make to mana...
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