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IEC 62304:2006 Medical device software - Software life cycle processes - Issued

A

alicecbrown

#11
I understand that we are held to the software standards that are prevalent at the time we put our medical device on the market. To that point, has IEC62304 been 'blessed' yet by the FDA?
the former standard has been obsoleted, and we don't appear to have a replacement other than our own SOPs, which we are planning to use.
thanks
alice Brown
 
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