The AAMI Software Risk Management Technical Information Report draft comment period ended March 1, 2004. Comments were generally positive.The next step is a working group meeting May 11-12, 2004 to resolve comments and do a final edit to prepare the document for formal ballot.
Contact one of the co-chairs if you are not a member of the AAMI committee and would like further information: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA at pxj@fdadr.cdrh.gov.