Device rac exam - Study guides, Class notes & Summaries

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report - Answer A During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical inv...

DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION

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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 - Answer ️️ -General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - Answer ️️ -13485:2016 Which entity affixes it's identification number near the CE Mark? - Answer ️️ -Notified Body, if involved in the conformity assessment Un-classif...

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 - 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 modification does not affect the intended use or alter the fundamental scientific technology of the device. If the...

Device RAC Exam Questions with 100% Correct Answers | Verified | Latest Update

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+. 1. 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: answer- C 2. A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requir...

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 - B A 510(k) submission for any Class III device MUST include: A. Clinical results summary B. Hazards analysis evaluation C. Stability evaluation D. Certification and summary - D A clinical study sponsor's representative conducts pe...

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+. 1. 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: answer- C 2. A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requir...

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 - Answer-C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbrevia...