B
Bridget
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
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