The INCOSE Biomedical-Healthcare Model-Based Systems Engineering (MBSE) Challenge Team has developed a reference model that uses SysML to represent a generic Medical Device infusion pump and a systems engineering process for planning, developing, and obtaining regulatory approval of a medical device. This presentation describes recent updates to the model that incorporates Buede’s textbook model for the engineering design of the system, and ensures its compliance with ISO 15288 and other applicable medical industry standards such as ISO 14971 Application of Risk Management to Medical Devices and IEC 62366-1 Application of Usability Engineering to Medical Devices. The model provides a clear road map that biomedical device developers can follow to integrate systems engineering activities with regulatory compliance activities to provide a more cohesive approach to developing effective and safe medical devices.
Presented at INCOSE Great Lakes Regional Conference October 23-25, 2015 Cleveland, Ohio
Website with the model
Website contains example of MBSE in the biomedical domain, using closed-loop drug delivery systems as the basis for the architectures.
Graduate Research Assistant,
at System-of-Systems Laboratory,
School of Aeronautics & Astronautics,
INCOSE Healthcare MBSE Challenge Team: Modeling for a Healthy Future