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ACAMPBELL
New to forum and new to medical devices... very lost. Have been going through forum postings and have learned allot!! Need to know if there is a copy of ISO14971 out there that I can download. 
ISO14971:2001 - Risk Management for Medical Devices - Help need copy
There is usually a Google ad in the sidebar with one company or another selling specifications. I'm sure the others will chime in with some other resources like Global Engineering, the ISO site, the ASQ and other sources.
We used to 'trade' some documents here but those days are long past.
We used to 'trade' some documents here but those days are long past.
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ACAMPBELL
Thanks for your reply. Im new to medical devices, and still have allot of homework ahead.
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agnesb
I would need help regarding the ISO 14971, what are the differences between the 2001 and 2007 version. What is to update in the risk management file.
Your support would be much appreciated.
Your support would be much appreciated.
I would need help regarding the ISO 14971, what are the differences between the 2001 and 2007 version. What is to update in the risk management file.
Your support would be much appreciated.
Have a look here. This is not an endorsement.
I would need help regarding the ISO 14971, what are the differences between the 2001 and 2007 version. What is to update in the risk management file.
Your support would be much appreciated.
Welcome to the Cove, Agnesb.
Refer this link - Application of Risk Management - ISO 14971:2007(E) Medical Devices
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cutcoag
The current standard is ISO 14971:2009. The cheapest I found it was at BSI for 189.00.
Hello Cutcoag and welcome to the Cove!
Just a clarification here, there´s no 2009 edition of the ISO 14971 standard. There´s a 2009 edition of the EN ISO 14971 standard, which is the european implementation of ISO 14971. This modification added annexes related to the european medical devices directive. You can see some more information in this thread: BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007
Y
Cheers!
Just a clarification here, there´s no 2009 edition of the ISO 14971 standard. There´s a 2009 edition of the EN ISO 14971 standard, which is the european implementation of ISO 14971. This modification added annexes related to the european medical devices directive. You can see some more information in this thread: BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007
Y
Cheers!
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cutcoag
Hi. You're right but 2009 effects CE, so I need to use it. I'm so busy I was hoping that someone would have a great Rick Management procedure and related forms and a CAPA procedure that ties in risk. I can't find anything out there. Helllllllllllllllllllllllllllllppp!
