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All Categories achievelivesession achievelivesessions audit preparation benefit-risk best practices collaboration complaints handling data effective communication effectiveness event tree analysis failure mode fda fmea harm hazard hazard analyis hazard analysis hazardous situation helpful tips interactive q&a iso 1491 training iso 14971 iso 14971 certification iso 14971 clause 10 iso 14971 compliance iso 14971 fundamentals iso 14971 training live series management review mdsap medical device patient safety postmarket surveillance probability process effectiveness qms audit quality culture reasonably foreseeable misuse risk analysis risk assessment risk based risk based auditing risk estimation risk evaaluation risk level risk management risk management file risk management plan risk perception safety safety culture sequence of events severity tools warning letter