RAC Exam Prep - EU MDD/AIMDD & MDR 2024 with complete solution;(Study Aid - RAC)

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-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 Define horizontal/Level I standards - Answer ️️ -General Standards relevant to all/wide range of product types define Semi-horizontal/level 2 standards - Answer ️️ -requirements applicable to a range of similar products (surgical instruments) Define vertical/level 3 standards - Answer ️️ -apply to a single product type or narrow range of products Define comparator device - Answer ️️ -established device bearing a CE Mark that is used as a reference in a clinical investigation NOT a predic