RAC Exam Prep 2023/2024 Answered 100% Correct

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-classified devices not requiring CE mark - ANSWER-Custom-made, Investigational, Compassionate/Orphan All ----- contributing to the intended purpose must be considered - ANSWER-Modes of action Define transient use - ANSWER-less than 60 minutes Define short-term use - ANSWER-between 60 minutes and 30 days A material is considered to have a biological effect if it actively and intentionally ---- - ANSWER-induces, alters, or prevents a response from tissues that is mediated by specific reactions at a molecular level refers to a material's degradation within the body and metabolic elimination of the resulting degradation products from the body - ANSWER-Absorption Combination devices are most often classified as - ANSWER-Class III MEDDEV 2.4/1^7 is a guidance for - ANSWER-Classification under MDD Standalone software is considered what type of device - ANSWER-Active Software that drives a device or influences its use automatically falls in to which classification? - ANSWER-That of the device If a manufacturer and an NB cannot agree on the classification who is consulted for a solution? - ANSWER-Competent Authority How can a manufacturer appeal the CA's decision of a classification? - ANSWER-in the national courts