Don't Take the Risk! Not All Software are Created Equal
A LifeScience Alley Featured Program
4/28/2010 |
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Time
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 2:30 pm
Event Description
CEOs, Inventors, Engineers, Engineering Managers, and Regulatory Managers - don't miss this powerful half-day seminar that will provide a mind-exchange on the hot topic of software risk management. Dr. Darkazanli of Boston Scientific will lead a team of experts in a session where you will:
• Learn from Dr. Birali - of the University of Minnesota's Supercomputing Institute - the role of High Performance Computing in simulation-based design and optimization of medical devices.
• Find out the software risk management issues for medical devices - ask Dr. Andy Anderson, Regulatory Affairs Principal Advisor at Regulatory and Clinical Research Institute, Inc. (RCRI) about regulatory considerations.
• Discuss software validation considerations with Russell Olson, Regulatory Affairs Senior Principal Advisor, RCRI, Inc.
• Learn Design Verification Test considerations with Greg Schultz co-founder and co-owner of Design Solutions, Inc.
• Examine the EN62304 Impact on Medical Device Development with Dan Sterling the founder and president of SterlingTech.
Speakers
Ammar Darkazanli, PhD, Senior Software Manager, Boston Scientific Corporation, CRM; H. Birali Runesha, PhD, Director of Scientific Computing and Applications, University of Minnesota - Supercomputing Institute; Andy Anderson, PhD, Principal Advisor, Regulatory & Clinical Research Institute, Inc. (RCRI); Russell W. Olson, Senior Principal Advisor, Regulatory & Clinical Research Institute, Inc. (RCRI); Greg Schultz, President, Design Solutions, Inc.; Dan Sterling, Founder and President, SterlingTech, Inc.
Ammar Darkazanli, PhD is a Senior Software Manager at Boston Scientific Corporation. He has over 17 years of experience in software development for medical applications. (more)
H. Birali Runesha, PhD is the Director of Scientific Computing and Applications at the University of Minnesota Supercomputing Institute (MSI). He has a Ph.D. degree (more)
Andy Anderson, PhD is a Principal Advisor at RCRI, Inc. He brings over 25 years of strategic regulatory, clinical, and research and development experience to RCRI.(more)
Russell W. Olson is a Senior Principal Advisor at RCRI, Inc. He has over 25 years of experience in the medical device industry, 15 years of which (more)
Greg Schultz has 22 years of product development experience, almost entirely in the medical field. He has extensive experience developing software ranging from (more)
Dan Sterling is the founder and president of SterlingTech. With 25 years of experience in safety critical software development including all types of Class II (more)
Topics
The following topics will be addressed:
Location
DoubleTree Park Place Hotel - 1500 Park Place Blvd., St. Louis Park, MN 55416 -- 952.542.8600 for front desk. Directions: Hwy. 394 to Park Place/Xenia exit - south to 16th St. - right on the corner.