Dec 212015
Applying Systems Engineering to Regulatory Compliance Activities for Medical Devices

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 […]