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Assurance Cases for Medical Devices

  • April 2011
  • By Charles B. Weinstock3787
  • In this presentation, Chuck Weinstock gives a brief introduction to assurance cases. He discusses how they are developed and why they are useful
  • Software Assurance
  • Publisher: Software Engineering Institute
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  • Abstract

    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 presentation 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 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.

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