Risk Management is a structured software approach for managing potential and known risks. Potential hazards are identified, causes determined and controls applied to reduce risk.

EZ Risk Manager™ helps you implement ISO 14971 risk management. The program is designed to run on Microsoft Windows XP and Vista operating systems.

EZ Risk Manager™ guides you through the ISO 14971 process of identifying potential hazards, causes and risk controls:

• Risk analysis. EZ Risk Manager™ helps you identify potential hazards and assign a severity level to each one.

• Risk evaluation. EZ Risk Manager™ helps you identify the causes of each hazard. You can define multiple causes for a hazard and assign an initial probability of occurrence to each. EZ Risk Manager automatically calculates the initial risk for each cause.
  

• Risk control. EZ Risk Manager™ helps you define and rate risk controls. The program lets you define one or more risk controls for a cause, and lets you assign a residual probability of occurrence for control. EZ Risk Manager™ then automatically calculates the residual risk for each risk control.

• Evaluation of overall residual risk acceptability. EZ Risk Manager™ lets you quickly verify the completeness of your risk control measures. Comprehensive, easy-to-read reports are generated by EZ Risk Manager to support your evaluation of overall residual risk acceptability. These reports become the basis of your risk management report and, when incorporated into the risk management file, demonstrate ISO 14971 compliance.

• Production and post-production information. EZ Risk Manager is your foundation for production and post-production risk management reviews. Generate interim reports after each risk management review to document compliance with the ISO 14971 goal of ongoing and continual risk management. Each interim report saved in the risk management file becomes conclusive evidence of your company’s continuing commitment to the ISO 14971 risk management process.

Any questions? Call or email — we are always glad to discuss ISO 14971 and EZ Risk Manager.

Contact us to obtain a free trial of EZ Risk Manager.

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