*AAMI Safety Assurance Case Course *

Safety Assurance Cases for Medical DevicesSeptember 30 – October 2, 2013 Arlington, Virginia

This 3 day course provides attendees with an understanding of safety assurance cases and how they can be used to demonstrate the validity of safety claims made for medical devices. It covers the elements of assurance cases, the structure and approach for using them to demonstrate medical device safety, how to create and review a safety assurance case with good arguments and evidence, and common logic fallacies seen in assurance cases.

*Alan Kusinitz and Sherman Eagles of SoftwareCPR are instructors of this course.*

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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