RAC Exam Prep - EU MDD/AIMDD & MDR | Verified | Latest Update 2024
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-made, Investigational, Compassionate/Orphan All ----- contributing to the intended purpose must be considered - Modes of action Define transient use - less than 60 minutes Define short-term use - between 60 minutes and 30 days A material is considered to have a biological effect if it actively and intentionally ---- - 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 - Absorption Combination devices are most often classified as - Class III
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rac exam prep eu mddaimdd mdr verified la
