EZ Risk Manager provides an automated, affordable solution to ISO 14971 Risk Analysis and Management.  Quickly define hazards, causes and risk controls and then generate the reports you need to prove ISO 14971 compliance. As you modify risk parameters, EZ Risk Manager automatically updates all affected forms and reports.

No more complicated spreadsheets to mess around with!

If you have to comply with ISO 14971, you need EZ Risk Manager. It pays for itself the first time used. Free 30-day trial.  

EZ Risk Manager™
helps you break ISO 14971 compliance
into a series of small, manageable steps

With EZ Risk Manager™

You Can Achieve ISO 14971 Compliance in Less Than 30 days.

Do it yourself or take advantage of our unique ISO 14971 Boot Camp.

Worried about implementing ISO 14971?

You should be.  ISO 14971:2009 Medical devices – Application of risk management to medical devices is the only international standard for risk management for medical devices, including in vitro diagnostic (IVD) medical devices. 

This standard is formally recognized by:

• United States Food and Drug Administration (FDA)
• European Union
• Health Canada
• Japan
• Australia

• The FDA requires risk management
• ISO requires risk management
  
• ISO 14971 is the world standard for risk management

The bottom line…you need to comply with ISO 14971

1. Read about EZ Risk Manager, an affordable, easy-to-use risk management & analysis program that saves you time and money. (Click here to read more)
2. Download the free 30-day trial
3. Try out the program for 30 days. Ask us a lot of questions
4.  Purchase EZ Risk Manager. Includes one year of free support and software upgrades
   
5. Implement your ISO 14971 solution. We can provide training and whatever help you need to achieve compliance within 30 days.(Click here for training info)