Summer Software Symposium:
Assuring Confidence in Predictable Quality of Complex Medical Devices
Predictable quality is a key aspect of today’s complex
medical devices. This workshop 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.
As a separate event on Thursday, July 17, we are happy to
announce a half day workshop on
“Evidence-based Development: Processes and Practices”
with
Dr. Jeremy Dick
(integrate Systems Engineering, U.K.).
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 (pdf slides)
Gordon Dosher
(Senior Reliability Manager, Medtronic)
|
| 9:45 - 10:15 |
Quality from a Customer Perspective (pdf slides)
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 (pdf slides)
Richard Chapman
(FDA Office of Science and Engineering Laboratories)
|
| 11:15 - 11:45 |
Toward Regulatory Adoption of Assurance cases (pdf slides)
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 (pdf slides)
Jeremy Dick (integrate Systems Engineering, U.K.)
|
| 2:30 - 2:45 |
Refreshment Break |
| 2:45 - 3:45 |
Evidence Based Certification: The Safety Case Approach (pdf slides)
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
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.
- Registration:
-
SSS '08 Registration Form
|
