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

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#11
Bridget said:
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
Bridget:

Look at this post by Cathy. I think it will help you. http://elsmar.com/Forums/showpost.php?p=64354&postcount=6
 
Elsmar Forum Sponsor
#12
Report

Hi Al:
I have seen Cathy's outline but I was hoping to see how one is used. However I fully understand that this could be confidential information and I may not get any offers to share a report. From what I understand the report is the condensed version of all of the other parts of risk management. If I give my mind a rest I am sure it will come to me in a couple of days.

Risk management seems like it will be a great help but with our products the only real hazard is allergic reactions along with breakage or swallow a small, small part.

I used to joke about job security but now it seems to be true as long as standards keep changing. Is anything else being changed in the near future that I might want to know about?
Thanks for watching over my progress.
Bridget
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#13
Bridget said:
Hi Al:
I have seen Cathy's outline but I was hoping to see how one is used. However I fully understand that this could be confidential information and I may not get any offers to share a report. From what I understand the report is the condensed version of all of the other parts of risk management. If I give my mind a rest I am sure it will come to me in a couple of days.

Risk management seems like it will be a great help but with our products the only real hazard is allergic reactions along with breakage or swallow a small, small part.

I used to joke about job security but now it seems to be true as long as standards keep changing. Is anything else being changed in the near future that I might want to know about?
Thanks for watching over my progress.
Bridget
Who said?
The one thing that is constant is change.
Are you on the FDA e-mail list? http://www.fda.gov/cdrh/subscribe.html
 
#14
FDA alerts

Al, I am getting the FDA emails but it is the ISO standards and EU directives that I fail to hear about changes in enough time. Since I have DSL access at my desk it is getting easier to monitor though.
Well off to finish the Risk Management project and start using it.
Thanks,
Bridget
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#15
Bridget said:
Al, I am getting the FDA emails but it is the ISO standards and EU directives that I fail to hear about changes in enough time. Since I have DSL access at my desk it is getting easier to monitor though.
Well off to finish the Risk Management project and start using it.
Thanks,
Bridget
Try subscribing to this sites "e-journal"

http://www.emergogroup.com/news.htm
 
#18
Thanks

Thanks for the link to e-journal Al. It seems like a good resource. Our EU reps website is also very helpful should you need another reference site.
mdi-europa.com
Bridget
 
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