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Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820

  • Thread starter QA Systems Manager
  • Start date
Q

QA Systems Manager

#1
Does anyone have knowledge of a resource for purchasing books that have a combination of ISO 13485 and at least the FDA Title 21 CFR Part 820? I was thinking this would be a good reference tool for internal auditors. Thank you,
 
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sagai

Quite Involved in Discussions
#3
Well, I do not know such book, however I have found useful to use the ISO13485+ISO14969+ISO19011 the 21CFR820+the guidances+ghtf documents+not for last the QSIT manual.
I have seen a comparison document, but that one had not too much use for me.
Regards, Szabolcs
 
G

Gert Sorensen

#4
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices handles each part of the QSR and relates it to 13485 and 14969 as applicable, and it has a reference table between 820 and 13485.

It is a really nice little book to have. :)
 

Marcelo

Inactive Registered Visitor
#5
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices handles each part of the QSR and relates it to 13485 and 14969 as applicable, and it has a reference table between 820 and 13485.
Great you remembered that. However, I just want to point out that it compares the QSR wih an older version of ISO 13485 (the 1996 version).

It's still a great book, though.
 
G

Gert Sorensen

#6
Ah, but you are thinking of version 1 by the legendary Kimberly Trautman. It was revised in 2008 to reflect the newer standards, this was done by Amiram Daniel and Ed Kimmelman.
 

Marcelo

Inactive Registered Visitor
#7
Ah, but you are thinking of version 1 by the legendary Kimberly Trautman. It was revised in 2008 to reflect the newer standards, this was done by Amiram Daniel and Ed Kimmelman.
Sorry, sorry, you are totally right, I've got Kim's book but not Ed's, and forgot the Ed's is the second edition.
 
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