Rac devices exam 2024 Study guides, Class notes & Summaries

RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic deve...

RAC DEVICES EXAM |NEWEST PRACTICE EXAM 2024 |ACTUAL COMPLETE QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |PRE-ASSESSED A+

RAC Prep Medical Devices Review 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 purpose ...

RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic deve...

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 - 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 requireme...

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...

FDA Time Frames (Device) RAC Exam 2024 | 35 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ Facility Registration - Devices - within XX days of application or manufacturing - 30 days Facility Re-Registration - Devices, Drugs & Biologics - Annual GLP & GCP Record Retention - 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Spon...

FDA Time Frames (Device) RAC Exam Questions & Answers 2023/2024 Facility Registration - Devices - within XX days of application or manufacturing - ANSWER-30 days Facility Re-Registration - Devices, Drugs & Biologics - ANSWER-Annual GLP & GCP Record Retention - ANSWER-5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB - ANSWER-Annual -...

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...

Device RAC Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified 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...