Schedule *
|
| TUESDAY,
MARCH 9, 2010 |
8:00am- |
9:00am |
Registration Open and Continental Breakfast |
9:00am- |
9:15am |
Welcome Remarks |
9:15am- |
10:15am |
Science in Decision Making at the U.S. Food and Drug Administration
Maggie Dietrich, U.S. Food and Drug Administration |
10:15am- |
11:00am |
Robotics in Healthcare: What the Future Holds in Standards
Joel Myklebust, U.S. Food and Drug Administration
Charles Sidebottom, Medtronic, Inc. |
11:00am- |
11:15am |
Break |
11:15am- |
12:15pm |
The New Human Factors Standards: ANSI/AAMI HE75:2009, Human factors engineering - Design of medical devices
Edmond Israelski, Abbott Laboratories
Ron Kaye, U.S. Food and Drug Administration
|
12:15pm- |
1:15pm |
Networking Luncheon |
1:15pm- |
2:00pm |
A Review of IEC 60601-1:2005, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Third Edition - Amendment
Charles Sidebottom, Medtronic, Inc. |
2:00pm- |
3:00pm |
An Overview of Electromagnetic Compatibility Standards in the Context of ANSI/AAMI ES60601-1:2005, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Third Edition |
3:00pm- |
3:15pm |
Break |
3:15pm- |
4:00pm |
An Update on Unique Device Identification (UDI)
Jay Crowley, U.S. Food and Drug Administration
Terrie Reed, U.S. Food and Drug Administration
|
4:00pm- |
5:30pm |
What You Need to Know About ISO/DIS 80369-1: Small bore connectors for liquids and gases in healthcare applications
Scott Colburn, U.S. Food and Drug Administration
Izabella Gieras, Mount Sinai Medical Center
Brad Noe, Becton Dickinson & Company
|
5:30pm- |
6:30pm |
Reception |
| |
WEDNESDAY,
MARCH 10, 2010 |
8:00am- |
9:00am |
Continental Breakfast |
9:00am- |
10:15am |
The Evolving Role of Simulation Testing in the FDA Approval Process
Jeff Cooper, Massachusetts General Hospital
Michael Wiklund, Wiklund Research & Design |
10:15am- |
10:30am |
Break |
10:30am- |
11:30am |
The Impact of IEC 80001: Application of risk management for IT networks incorporating medical devices on Device Manufacturers
Brian Fitzgerald, U.S. Food and Drug Administration; Ken Fuchs, Draeger Medical Systems
|
11:30am- |
12:30pm |
FDA Discussion on ISO/TC-84: Devices for administration of medicinal products and intravascular catheters
Harold Yeager, Eli Lilly & Company
Anthony Watson, U.S. Food and Drug Administration
|
12:30pm- |
2:00pm |
Luncheon Program: "The State of the FDA" with Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration
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| * Topics and time may be subject to change. |
