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

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

• Risk analysis. EZ Risk Management™ helps you identify potential hazards and assign severity levels to each hazard.
  

• Risk evaluation.   EZ Risk Management™ 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. The program will automatically calculate the initial risk for each cause.    
  
• Risk control. EZ Risk Management™ helps you define and prioritize risk controls.  The program helps you define one or more risk controls for each cause, and lets you assign a residual probability of occurrence for each one. EZ Risk Management™ automatically calculates the residual risk for each control.
  
   
• Evaluation of overall residual risk acceptability.  EZ Risk Management™ lets you quickly verify the completeness of your risk control measures. Comprehensive, easy-to-read reports are generated by EZ Risk Management™ to support your evaluation of overall residual risk acceptability.  These reports become the basis of the risk management report and, when incorporated into the risk management file, demonstrate ISO 14971 compliance.
  
  
  
• Production and post-production information.  EZ Risk Management™ is the 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 Management. 

Contact us to obtain a free demo version of EZ Risk Management.

(Read about BOOT CAMP)