ISO 14971 replaces EN 1441 - Risk Analysis and Technical Files/Device Master Files

#1
I need some help regarding Risk Analysis and the Technical Files/Device Master Files.
I have found out that ISO 14971 replaces EN 1441 which we used for risk analysis to set up the technical files in the beginning of our quality system. I am wondering if anyone out can point out any differences or perhaps may have already created a cross reference chart that points out the differences between the two. I have just started major revisions to our technical files when I first learned about the new standard. It is very important that I get the files revised before our next audit in September 2004.
Thanks,
Bridget
 
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Al Rosen

Holed-up in a Hotel in South Florida
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#2
Bridget said:
I need some help regarding Risk Analysis and the Technical Files/Device Master Files.
I have found out that ISO 14971 replaces EN 1441 which we used for risk analysis to set up the technical files in the beginning of our quality system. I am wondering if anyone out can point out any differences or perhaps may have already created a cross reference chart that points out the differences between the two. I have just started major revisions to our technical files when I first learned about the new standard. It is very important that I get the files revised before our next audit in September 2004.
Thanks,
Bridget
Bridget:

Do you have a copy of 14971? Risk analysis is only a part of 14971.
 
#3
Oh?

Hi Al!
I have the standard (14971) and have browsed through it. I will admit that new standards and directives are changes I don't look forward to. I will look it over again tonight (for homework). Can you save me time and tell me what the rest of it is for?

I have had another idea--what if I just created controlled ammendments to my technical files instead of revising them, and documented this in the techical file procedure would that be acceptable? :bonk: :bonk:

Anything else you are willing to share I would appreciate. I also have just received notice that the deadline for a new directive for MSDS is growing near also and that may take a lot of time.....
Thank you,
Bridget
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#4
Bridget said:
Hi Al!
I have the standard (14971) and have browsed through it. I will admit that new standards and directives are changes I don't look forward to. I will look it over again tonight (for homework). Can you save me time and tell me what the rest of it is for?

I have had another idea--what if I just created controlled ammendments to my technical files instead of revising them, and documented this in the techical file procedure would that be acceptable? :bonk: :bonk:

Anything else you are willing to share I would appreciate. I also have just received notice that the deadline for a new directive for MSDS is growing near also and that may take a lot of time.....
Thank you,
Bridget
Bridget:

Look at the flowchart (fig 2, I believe) in 14971. Perhaps you can revise your procedure/plan to include performing the risk analysis periodically (maybe annually), utilyzing data from users/field experience. You can feed your customer complaint data into the risk management system.
 
#5
Thanks

Al,
OK, now it is starting to make more sense.
What is required is a continual risk management system, not just a risk anaylsis that is done during the design stages, is that correct?
Thanks
Bridget
 
Last edited:
W

wrodnigg

#6
In a few words:

"Risk Management" is much more than "Risk Analysis" or "Risk Assessment"
(Fig. 1)

You also have to mitigate risks (risk control).

As Al already mentioned just follow Fig.2 (you now have to do risk assessments periodically, you have to include data from post market surveillance in your rm-file).

Here are some Articles:
http://www.devicelink.com/mddi/archive/03/11/001.html
http://www.devicelink.com/ivdt/archive/03/07/010.html
http://www.devicelink.com/mddi/archive/03/02/005.html

And a nice introduction from the IMB-Newsletter (Page 5):
http://www.medicaldevices.ie/pdfword/Issue07_February_2004.pdf
 
Last edited by a moderator:
#7
SO Far So GOOD !?

Thanks to all so far, the articles have been helpful. I am still open to any further suggestions or examples. I realize I have a late start on this but we have one of those notified bodies with terrible communication skills and we did not hear of this until last November during our audit. Then I found this forum and feel like there is a great network of knowledge and support here.
:applause:
Bridget
 
C

Cathy

#8
Bridget,
If you look back at threads from around December 2003 there were 2 or 3 threads dedicated to discussion on risk management based around this standard, If you search for these you will see some example templates and procedures for this standard.
 
#9
Examples

Thanks Cathy,
I found the templates for the forms but was unable to find any for the procedure. At the moment I am trying to create forms with all of the requirements. I hope this will keep the procedure brief.
Bridget
 
#10
Risk Management Report

I am completing the risk management process but only thanks to all of the cove members who sent links to other documents and provided examples. I have finished a procedure and five forms that complete the process for us. Of course by the time our audit comes around I know there will be revisions from nonconformances, I couldn't be that lucky.

I have one more favor to ask-would anyone be willing to share an example of their completed risk management report for a class I or IIa device? I am having difficulty visioning this last document.
Regards,
Bridget
 
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