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Procurers of medical devices need confidence that the medical devices they buy have predictable reliability, safety, and effectiveness. Developers of medical devices need confidence that they can predictably demonstrate quality. Regulators of medical devices need confidence that the device is safe and performs as claimed by the manufacturer.
Current standards for critical systems, such as many complex medical devices, are typically prescriptive, the product must be developed using a prescribed process. Such standards rest on the assumption that following a "good" process will result in a "good" product.
An assurance case, on the other hand, is a structured argument that presents evidence and supporting information that is intended to demonstrate that a product possesses desirable qualities such as safety and reliability.
Recent guidance from the FDA is moving away from “process based assurance” towards “evidence based assurance” and using assurance cases is the approach taken to satisfy this requirement. Currently, FDA mandates the use of assurance cases in the development of infusion pumps, and assurance cases are likely to be used for other devices in the near future.
At this event, we will provide an overview and in-depth discussion of assurance cases and hear the latest news related to this technique from FDA representatives.
This year's Summer Software Symposium is sponsored by SoftwareCPR.
|08:00 - 08:30||Breakfast and Registration|
|08:30 - 09:14||
Introduction and Goals of Symposium.
Assurance case introduction and overview.
Mats Heimdahl (Professor and Director of U of M Software Engineering Center)
|09:15 - 10:45||
Keynote Address: Effective Safety Cases: Experience and Strategies
Dr. Tim Kelly (University of York, UK)
|10:45 - 11:15||Refreshment Break|
|11:15 - 12:00||
Safety assurance cases: What the medical device industry is doing
Sherman Eagles (SoftwareCPR)
|12:00 - 13:00||Lunch (provided)|
|13:00 - 14:30||
Safety Assurance Cases for Infusion Pumps - Lessons Learned
Richard Chapman (Branch Chief, General Hospital Devices Branch, FDA)
|14:30 - 15:00||Refreshment Break|
|15:00 - 16:15||
Ask The Experts Panel with Speakers
Moderator: Mats Heimdahl
|16:15 - 16:30||
Closing and Invitation to SSS 2012
Do not forget to register for the event as well as the outstanding tutorials on Friday.
SSS '11 is the third in a series of summer symposia on best practices in software engineering and development in the embedded and critical systems domain, organized by the University of Minnesota Software Engineering Center. Each year, we choose a theme, and present a full day of stimulating talks, workshops, tutorials, and other activities. We will do our best to make it practical, relevant, free of hype, and non-commercial.
This year’s theme is “Assurance Cases: New Techniques and New Guidance.”