This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf is a SoftwareCPR training aide and should not be used blindly to fill in the blanks. It is a partial example of a software risk analysis procedure and report. It is just one partial approach that...Read More

This link contains an August 2007 draft Korean KFDA guideline entitled “Medical Software Evaluation Guidelines.” This guidance focuses on examining information about the software and what it does, rather than how it may fail or risk management for those failures. There is significant emphasis and specificity in revision numbering and change control. Korea KFDA Software GuidelineRead More

Company: Baxter Healthcare Corp Date of Enforcement Report 3/11/2009 Class:l PRODUCT Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163 These products were manufactured and distributed from February, 1997 through December, 2008. REASON The company identified software and battery usage failures...Read More