Rac medical devices exam Study guides, Class notes & Summaries

RAC Exam Prep - EU MDD-AIMDD & MDR Similar but more detailed than the Essential Requirements - ANS-General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - ANS-13485:2016 Which entity affixes it's identification number near the CE Mark? - ANS-Notified Body, if involved in the conformity assessment Un-classified devices not requiring CE mark - ANS-Custom-made, Investigational, Compa...

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 primary purpose Exempt device - ANSWER-Exempt from 510(k) if: -Diagnostic de...

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...

RAC Device Exam Questions and answers Graded A+ What did the safe medical device act do? - ANSExtended AE reporting to user facilities, required 510ks with SE, recall authority General controls - ANSEstablishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? - ANSClass 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA ...

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...

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 Exam Prep 2023 (EU) Qs&As Who is the European Medicines Agency (EMA) - ANSWER-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 individual regulatory bodies in Europe. Relevance of EMA in EU - ANSWER-founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous scientific standards and by prov...

Device RAC Exam Questions & Answers With Accurate Explanations 2023 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 - ANS-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 inte...

RAC Devices Exam Prep 2024 Questions and Answers Correct Who is the European Medicines Agency (EMA) - Answer ️️ -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 individual regulatory bodies in Europe. Relevance of EMA in EU - Answer ️️ -founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous ...

RAC DEVICES Exam Prep 2024 | 60 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented one-third of its subjects properly . What is the FIRST thing the company needs to do? A.Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator D. Re-consent all improperly conse...