Day

April 16, 1999
4/16/99 Class II Colleague 3 Volumetric Infusion Pump (Triple Channel). Baxter Healthcare 6,992 units. A software communication error occurs predominately when all three channels are in use, causing an alarm codition that will stop the function of all of the channels in use. The pump will alarm appropriately, alerting the user of the failure state....
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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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