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