*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.*

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.