Software to Manage Compliance to ISO 14971 (Medical Device Risk Management).

[TJG954 - 2009]

Can anyone recommend a program we can purchase to lead us through 14971 compliance?

Thanks for your help.
Ted

 

[Marcelo]

FMEA for medical devices from Dyadem - www.dyadem.com. It has some limitations (it focus on FMEA) but someone who knows the standard can use it to it´s full potential and avoid the pitfalls.

 

[TJG954 - 2009]

Thank you for the reply Mmantunes. I was starting to think no one was dealing with 14971.

 

[yodon]

Well, it *is* a Risk-y business.

We just brute-force it with a semi-standard excel template.

 

[sar727]

Complaince to ISO 14971 means streamlinining your risk management process and try to integrate/roll up all risk to have visibility into higher risks across the business unit/organization.

There are many software companies out there who might help. I have used Dyadem for the same.

 

[TDX-2 - 2011]

I am with a very small company...is Dyadem's software prohibitively expensive?

 

[Stijloor]

I am with a very small company...is Dyadem's software prohibitively expensive?

"Expensive" is a relative term. You should weigh the costs associated with a product/device failure against the investment of acquiring the appropriate software. I am sure that the software companies you should consider can provide you with the data you need to help make the best decision.

Stijloor.

 

[TDX-2 - 2011]

OK...I deserved that...poorly worded question asked too late in the day.

Thanks anyway.

 

[Stijloor]

OK...I deserved that...poorly worded question asked too late in the day.

Thanks anyway.

No, I don't think the question was poorly worded.

I just hope that you can find the info that will help you to move forward with selecting the software you may need. That's all.

Stijloor.

 

[Watchwait]

Specific Question r.e. ISO 14972:2007...

This revision of the document does not include the "Ability to Detect Defect" column in it's matrix. It only addresses the product of "Severity" & "Frequency". A typical FMEA includes an assessment of the ability to detect any given defect & includes this factor in the Risk Priority Number. Stated another way, an FMEA integrates the impact of Severity, Frequency & Detection. ISO 14971:2007 seems to have done away with the "Detection" component. We are really struggling with this issue & would appreciate any input from the group in this regard. Tks!