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

T

TJG954 - 2009

#1
Can anyone recommend a program we can purchase to lead us through 14971 compliance?

Thanks for your help.
Ted

:thanks:
 
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T

TJG954 - 2009

#3
Thank you for the reply Mmantunes. I was starting to think no one was dealing with 14971.

:lmao:
 
S

sar727

#5
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.
 

Stijloor

Staff member
Super Moderator
#7
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.
 
T

TDX-2 - 2011

#8
OK...I deserved that...poorly worded question asked too late in the day.

Thanks anyway.
 

Stijloor

Staff member
Super Moderator
#9
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. :agree:

Stijloor.
 
W

Watchwait

#10
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!
 
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