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Summer Software Symposium: Assuring Confidence in Predictable Quality of Complex Medical Devices

Date of Event: 
Wednesday, July 16, 2008 - 9:00am
Location: 
McNamara Alumni Center

Predictable quality is a key aspect of today's complex medical devices. The Summer Software Symposium: Assuring Confidence in Predictable Quality of Complex Medical Devices will explore the requirements of different stakeholders for predictability and discuss some techniques for demonstrating confidence in the assurance of quality that may be useful in satisfying these requirements.

Procurers of medical devices need confidence that the medical devices they buy have predictable reliably and will be available when they are needed. Developers of medical devices need confidence that they can predictably demonstrate quality. They need to predict how much verification and validation will be needed and when it will be completed. Regulators of medical devices need confidence that the device is safe and performs as claimed by the manufacturer, and that their review can be completed to meet statutory schedule requirements. Techniques for demonstrating assurance that a medical device satisfies its quality objectives will be explored to determine whether these techniques can be used to provide increased predictability in device quality, as well as development and approval schedules.

Agenda

9:00 - 9:15 Introduction, Overview, and Goals of Workshop
Mats Heimdahl (Professor and Director of U of M Software Engineering Center)
Sherman Eagles (Medtronic Technical Fellow (retired), Chair AdvaMed Medical Device software working group)
9:15 - 9:45 Quality from a Manufacturer Perspective
Gordon Dosher (Senior Reliability Manager, Medtronic)
9:45 - 10:15 Quality from a Customer Perspective
Rick Hampton (Wireless Communications Manager, Partners Healthcare System, Boston, MA)
10:15 - 10:45 Refreshment Break
10:45 - 11:15 Quality from a Regulatory Reviewer Perspective
Richard Chapman (FDA Office of Science and Engineering Laboratories)
11:15 - 11:45 Toward Regulatory Adoption of Assurance cases
Brian Fitzgerald, Deputy Director (FDA Office of Science and Engineering Laboratories)
11:45 - 12:15 Panel Discussion with Speakers
Moderator: Sherman Eagles
12:15 - 1:30 Lunch
1:30 - 2:30 Progressive Assurance using Evidence-based Development
Jeremy Dick (integrate Systems Engineering, U.K.)
2:30 - 2:45 Refreshment Break
2:45 - 3:45 Evidence Based Certification: The Safety Case Approach
Tim Kelly (University of York, UK)
3:45 - 4:15 Panel Discussion with Speakers
Moderator: Mats Heimdahl
4:15 - 4:30 Closing and Invitation to Next Years Event
Mats Heimdahl, Sherman Eagles

SSS '08 is the first in a planned annual 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 “Assuring Confidence in Predictable Quality of Complex Medical Devices.”

When:
Wednesday, July 16th 2008, 9:00-16:30
Registration and continental breakfast start at 8:30.
Where:
University of Minnesota, Minneapolis Campus, McNamara Alumni Center, at the corner of Oak and Washington
Cost:
There will be no charge for this inaugural event. Nevertheless, we will provide continental breakfast, coffee break, and conference materials.
Parking:
Park in the University Avenue Ramp
Lodging:
The Radisson University Hotel is less than a block away.