EZ Risk Management

ISO 14791 Risk Management Software

Compliance in 30 days!

TX
ph: 512.788.6010

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


With EZ Risk Management™

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 14971:2007 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 Management™  is the solution

 

 Your Roadmap

  1. Read about EZ Risk Management, an easy-to-use risk management software program that saves you time and money. (Click here to read more)
  2. Contact us to obtain a free 30-day demo version
  3. Try out the program for 30 days. Ask us a lot of questions
  4.  Purchase EZ Risk Management. If you buy within the 30-day evaluation period, you will get a 25% discount
  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)

 

(Read more about EZ Risk Management)

What We Do

We help you achieve ISO 14971 compliance. Our goal is to succeed one customer at a time:

  • Do it yourself. EZ Risk Management gives you the power to  implement ISO 14971 without spending money on expensive consultants
  • Ask for a little help. We can help guide you through the areas you need help with  
  • ISO 14971 BOOT CAMP. We walk you through the whole process, giving the the tools to do-it-yourself from then on. Compliance within 30 days - guaranteed!
 

FREE DEMO!

Call or email if you have any questions about EZ Risk Management or ISO 14971. 

Better yet, we can send you a free EZ Risk Management demo.  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 hearing from you.

(Click here for free demo) 

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TX
ph: 512.788.6010