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Free Software Engineering Institute Webinar Discusses Assurance Cases and Recent FDA Guidance on their use for Medical Devices

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Pittsburgh, Pa., April 7, 2011—Recently the U.S. Food and Drug Administration (FDA) issued guidance to infusion pump manufacturers recommending the use of an assurance case to justify claims of safety. A free webinar from the Carnegie Mellon Software Engineering Institute (SEI), held at 1:30 p.m. ET Thursday, April 28, 2011, will provide a brief introduction into assurance cases, why they are useful, how they are developed, and how they can be used to help assure the safety of medical devices.

Presented by Chuck Weinstock, a member of the technical staff in the SEI’s Research Technology and Systems Solutions (RTSS) program, this 60-minute webinar, Assurance Cases for Medical Devices, will take an in-depth look at assurance cases, which are similar in form and content to a legal case. An assurance case specifies a claim regarding a property of interest, evidence that supports that claim, and a detailed argument explaining how the evidence supports the claim. Assurance cases have been used in Europe for more than 15 years to argue safety cases for military, avionics, railway, and nuclear systems. The FDA is the first U.S. organization to officially encourage their use in assessing safety-critical systems.

For more information about the SEI Webinar Series, or to register for the Assurance Cases for Medical Devices webinar, please visit www.sei.cmu.edu/events/webinars/index.cfm.

About the Presenter
Chuck Weinstock has been with SEI for more than 26 years. He is currently a senior member of the technical staff in the System of Systems Software Assurance Initiative within the SEI’s RTSS program. With his colleague John Goodenough, Weinstock authored the 2009 SEI technical note Towards an Assurance Case Practice for Medical Devices. He has been active in the dependable computing field since the late 1970's when he worked at SRI International on the SIFT fault-tolerant computer. He earned a bachelor's degree in mathematics, a master of science degree in industrial engineering, and a doctorate in computer science, all from Carnegie Mellon University.

About the Software Engineering Institute
The Software Engineering Institute (SEI) is a federally funded research and development center sponsored by the U.S. Department of Defense and operated by Carnegie Mellon University. The SEI helps organizations make measurable improvements in their software engineering capabilities by providing technical leadership to advance the practice of software engineering. For more information, visit the SEI website at www.sei.cmu.edu.

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