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.