Sessions
Handouts (in PDF format) for the following sessions are available by clicking on the speakers name. If the name is not linked, the handout is not yet available. |
| WEDNESDAY,
MARCH 19, 2008 |
8:45am- |
9:00am |
Welcome Remarks
- Dave Osborn, Philips Medical Systems |
9:00am- |
10:45am
|
Medical Device Connectors |
- Jay Crowley, U.S. Food and Drug Administration
- Scott Colburn, U.S. Food and Drug Administration
- Izabella Gieras, Beaumont Services Company, LLC
- Brad Noe, Becton Dickinson & Company |
11:00am- |
12:30pm |
Validation of Software for Regulatory Processes |
- Denise Stearns, Still River Systems
- Rick Chapman, U.S. Food and Drug Administration |
1:30pm- |
3:30pm |
The Impact of Standards and Regulation in the Global Medical Device Market |
- Ames Gross, Pacific Bridge Medical
- Dave Osborn, Philips Medical Systems
- Dr. Trudy Phelps, Association of British Healthcare Industries Limited (see below) |
Handout 1
Handout 2
Handout 3
|
Handout 4
Handout 5 |
Handout 6
Handout 7 |
3:45pm- |
4:45pm |
The Future of Regulation and Standards for Emerging Technologies |
- Ashley Boam, U.S. Food and Drug Administration
- William A. Herman, U.S. Food and Drug Administration |
| |
THURSDAY,
MARCH 20, 2008 |
8:30am- |
9:00am |
Briefing on the Standards Development Process |
| - Joseph Lewelling, AAMI |
9:00am- |
9:45am |
A Discussion of Recent Changes to the Risk Management Standard 14971, and the Adoption of IEC 60601-1 and its Collateral Standards |
- Carol L. Herman, U.S. Food and Drug Administration
-
Charles Sidebottom, Medtronic, Inc. |
9:45am- |
10:15am |
Best Practices in Documenting Use of Standards in 510(k) Submissions |
- Carol L. Herman, U.S. Food and Drug Administration
- Janine Morris, U.S. Food and Drug Administration |
10:15am- |
11:15am |
The IT Network Project: An Update from the TC 215 JWG 62A |
- Sherman Eagles, Medtronic, Inc.
- Brian Fitzgerald, U.S. Food and Drug Administration |
11:15am- |
Noon |
Global Harmonization Task Force Update |
| - Timothy Ulatowski, U.S. Food and Drug Administration |
Noon- |
1:15pm |
Dr. William Heetderks, Associate Director for Extramural Science Programs, National Institute of Biomedical Imaging and Bioengineering |
| |
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