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RAC Exam Prep - EU MDD/AIMDD & MDR | Verified | Latest Update 2024
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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
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