Rac Medical Devices Exam Questions And Answers With Complete Solutions

A submission that requires FDA inspection to ensure the manufacturing facilities, methods, and controls are in compliance with the Quality System (QS) regulation is: A. 510(k) B. Humanitarian Device Exemption (HDE) C. PMA D. Investigational Device Exemption (IDE) {Ans: C. PMA}EU Conformity Assessment procedures are located in which Annexes to the MDR? A. Annex I-III B. Annex I-X C. Annex IV-V D. Annex IX-XI {Ans: D. Annex IX-XI}The Quality System Requirement to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, is called: A. Design review B. Design input C. Design verification D. Design and development planning {Ans: B. Design input (this info is in the Federal Register 21 CFR Part 820, Subpart C)}Who assumes responsibility for compliance with the MDR by drawing up the EU Declaration of Conformity? A. The Competent Authority where the authorized representative is located B. Medical Device Coordination Group C. The manufacturer D. The Notified Body {Ans: C. The manufacturer}For a Class I device that is not sterile, not reusable and does not have a measuring function, EU