smdara Posted May 4, 2016 Share Posted May 4, 2016 I know the FDA requires approval of blood bank computer systems, but wondering if each version upgrade needs separate approvals as well? Thanks for your help! Link to comment Share on other sites More sharing options...
David Saikin Posted May 4, 2016 Share Posted May 4, 2016 Yes. A BBIS is considered a medical device. Upgrades are FDA approved and also require on site validation of changes. Link to comment Share on other sites More sharing options...
Gkloc Posted May 5, 2016 Share Posted May 5, 2016 As David said yes. The computer system we are using has an upgrade out that we will be upgrading to. There are companies out there that will perform the software validation for you, if you are lucky enough to have the budget for it. Link to comment Share on other sites More sharing options...
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