Smarteeva Risk Management
Smarteeva’s Risk Management tool is integrated directly with Complaints, Adverse Events, and all post-market modules. Risk assessments trigger automatically when a complaint is created. Scoring uses FMEA/pFMEA/dFMEA methodologies with severity, occurrence, and detection ratings. Interactive dashboards provide real-time risk visibility across products, geographies, and time periods.
Unlike standalone risk tools, Smarteeva’s risk management shares the same data model as complaint handling and regulatory reporting. When complaint data changes, risk scores update automatically. No re-entry. No version conflicts. No organizational silos between quality and risk teams.
What You Will Learn
How automatic risk assessment works inside the complaint workflow. How FMEA/pFMEA/dFMEA scoring is configured and maintained. How AI detects emerging risk patterns using decision trees and adaptive statistical thresholds. How interactive dashboards give quality, clinical, and manufacturing teams a shared risk view.
Who This Is For
Quality leaders evaluating how to integrate risk management with complaint handling. Regulatory professionals preparing for EU MDR audits where risk integration is expected. Operations teams looking to replace spreadsheet-based risk tracking with real-time, connected dashboards.
