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In this half-day seminar, attendees will learn how to minimize the impact of IEC 62304 on the software development process; leverage the benefits of static analysis and unit testing to reduce software risk; and deliver the highest quality medical device software possible.
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As an accepted standard for the safe design and development of medical device software, IEC 62304 prescribes a set of processes, activities and information that, if followed, will support FDA compliance. To be compliant, manufacturers must make sure that their software lifecycle is supported by a solid quality and risk management strategy.
Who Should Attend:
Cost:
- Software development team leads and managers
- Software developers and engineers
- Head of Development/Engineering teams
- Quality and regulatory compliance teams
Complementary
Sponsored by:
Minneapolis Marriott City Center
30 South 7th St. Minneapolis, MN 55402
Map and Directions
30 South 7th St. Minneapolis, MN 55402
Map and Directions
When:
Where:
Thursday January 13, 2011 | 9:00am-1:00pm CST
Presentations:
IEC 62304 Impact on Medical Device Development
Daniel Sterling, President, SterlingTech
The Role of Static Analysis in an Effective Risk Management Strategy
Todd Landry, Senior Product Manager, Klocwork
Achieving FDA Software Validation Compliance
Lynda Gaines, Senior Account Representative, Vector Software
Daniel Sterling, President, SterlingTech
The Role of Static Analysis in an Effective Risk Management Strategy
Todd Landry, Senior Product Manager, Klocwork
Achieving FDA Software Validation Compliance
Lynda Gaines, Senior Account Representative, Vector Software
