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.
The SEI Concept Lab produces proof-of-concept demonstrations that explore how new software and systems engineering technologies and their associated practices can provide technical insight. The demonstrations also support substantive technical and business claims for these technologies and practices with sound, validated, and accurate results.
Kurt Wallnau, a senior researcher in the SEI’s Research, Technology, and System Solutions (RTSS) Program, believes that systems that combine social intelligence, computational intelligence, and pervasive sensing will define the field of software and systems engineering for decades to come. Wallnau is leading an effort to create a concept lab to demonstrate such systems, among others, and the software engineering technology needed to design and operate them.
To learn more about the SEI Concept Lab, read this story on the SEI website.
Thursday, May 13, 2010
Time: 1:00 PM – 2:00 PM EDT
Many organizations are associated with producing, using, or funding technologies, practices, and policies purported to address assurance—a justified level of confidence that systems (and systems of systems) will function as intended within their operational environments. Understanding the value these solutions provide to assurance is often indirect and unclear. Where are the critical gaps in available technologies and practices? Where should resources be invested to gain the most benefit? To accelerate the formation and adoption of solutions, a more systematic approach is needed to model the assurance landscape.
The SEI and the U.S. Army Aviation and Missile Research Development and Engineering Center (AMRDEC) recently began a one-year engagement that aims to develop a comprehensive approach to overcome deficiencies with the testing now being done to validate software and system reliability. This comprehensive approach will include the development of a roadmap for the research and application of technologies such as model-based engineering, assurance cases, analytical tools, and industry standards, such as the Architecture Analysis and Design Language (AADL) in the assessment and validation of complex system reliability.
Read more here.