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
Where do I start?
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:
- I don’t want to bring in a bunch of expensive consultants
- I want a do-it-yourself approach. After all, who knows more about my product than my employees?
- I want a solution that can be applied to future products
- I want someone who will back me up during an FDA or ISO audit if there are questions about my ISO 14971 compliance
EZ Risk Manager™ is the solution
Your Roadmap
- 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)
- Download the free 30-day trial
- Try out the program for 30 days. Ask us a lot of questions
- Purchase EZ Risk Manager. Includes one year of free support and software upgrades
- 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)
(Read more about EZ Risk Manager)
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