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Visible to the public Draft-RIL-1101-public


Visible to the public Draft-RIL-1101-public_Rev3.pdf


Visible to the public Thoughts on Assurance Cases


Visible to the public  Assurance Case Brainstorming Meeting
Mar 19, 2012 12:23 pm - Mar 20, 2012 12:23 pm EDT

FDA/CDRH/OSEL (Office of Science and Engineering Laboratories)

The purpose of the meeting is to bring academics working on assurance case research and regulators considering assurance case use together to brainstorm ideas on what a generic (safety) assurance case should consist of. We also hope to gather thoughts on what current technology offers in terms of establishing sufficient evidence.


Visible to the public Organizing the shared space

Paul: In the 2-day "brainstorming" have you come up with some topics on which discussion should continue in this space? In particular, I would like to see topics or discussion threads on issues that are cross-domain (of course examples from the medical device field are fine - people relate to them better anyway). For example, consider the topic "CONFIDENCE." An issue that may be of broad interest: Why should a confidence case be an entity distinct from a safety case? Confidence should be a property of the evidence or the argument and, as a result, a property of the claim.