Your Shortcut to ISO 14791 Compliance
Thanks to all who visited us at the Regulatory Affairs Professional Society Convergence.
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.
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:
- 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
Join the crowd – you’re not alone. Companies are struggling to implement
ISO 14971 into their quality management system.
Like you, they face the following problems:
EZ Risk Manager™ is the solution
We help you achieve ISO 14971 compliance. Our goal is to succeed one customer at a time:
Call or email us if you have any questions about EZ Risk Manager or ISO 14971.
Better yet, download a free trial of EZ Risk Manager. Try it out for 30-days at no obligation. You will agree the program pays for itself the first time it is used.
Please contact us anytime! We look forward to answering your questions.