risk-management-specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle. Establish risk management process per ISO 14971. Identify hazards and estimate risks systematically. See: references/risk-analysis-methods.md Evaluate risks against acceptability criteria. Implement and verify risk control measures. Monitor and update risk management throughout product lifecycle. Risk Matrix Calculator Features: - Risk Management Planning Workflow - Risk Analysis Workflow - Risk Evaluation Workflow - Risk Control Workflow - Post-Production Risk Management - Risk Assessment Templates - Decision Frameworks - Tools and References - Define scope of risk management activities: - Medical device identification - Lifecycle stages covered - Applicable standards and regulations - Establish risk acceptability criteria: - Define probability categories (P1-P5) - Define severity categories (S1-S5) - Create risk matrix with acceptance thresholds - Assign responsibilities: - Risk management lead - Subject matter experts - Approval authorities - Define verification activities: - Methods for control verification - Acceptance criteria - Plan production and post-production activities: - Information sources - Review triggers - Update procedures - Obtain plan approval - Establish risk management file - Validation: Plan approved; acceptability criteria defined; responsibilities assigned; file...