Risk Management
Course length: 1 Day
Facts
Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)
Background:
Risk management is a fundamental step for medical device manufacturers to demonstrate compliance with the EU Directives for medical devices, ensuring the safety of patients and users. Risk management has been conducted following the principles laid out in ISO 14971.
Content:
Risk Management planningRisk AnalysisRisk EvaluationRisk ControlResidual RiskRisk Management ReportProduction and postproduction information
Who Will Benefit:
The course will introduce the main elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle.