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BIOMEDigital 2020 Session Viewer

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Driving Complex Medical Device Design Control

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.



The Advanced Manufacturing Technology Series Asia • North America • South America Learn More »