On Thursday, April 28 from 1:30 to 2:30 Eastern time, Chuck Weinstock of the SEI will present a free SEI webinar, titled “Assurance Cases for Medical Devices.”
About the Webinar
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. An assurance case is somewhat similar in form and content to a legal case. It 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.
This webinar will include a brief introduction to assurance cases, why they are useful, how they are developed, and how they can be used to help assure the safety of medical devices.
About the Speaker
Chuck Weinstock has been with SEI for more than 25 years. He is currently a senior member of the technical staff in the System of Systems Software Assurance Initiative within the SEI’s Research, Technology, and System Solutions program. With his colleague John Goodenough, Weinstock wrote 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 1970s 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.