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Larry Sampson (Senior Director of Medical Device Processes, Siemens Digital Industry Software)
Date: Thursday, November 5
Time: 12:00pm - 1:00pm
Track: Innovation Power Hour
Vault Recording: TBD
Integration of model based systems engineering, agile software development, ISO 14971 risk management, and external standards into a cohesive design development strategy.
Join us in discussing how to develop a comprehensive product definition in the context of the Medtronic open-source PB560 ventilator data. In this discussion we will show an example of how to develop a systems functional model, progress functions to product requirements, integrate user risk controls, and provide evidence of compliance by completion of a comprehensive product and process verification and validation test program.