System Mgmt for Medical Device. 3 credits, 3 contact hours

Catalog description

This course will provide a detailed overview of Project Management techniques and methods applied to medical devices and show the integration of medical device Design Controls from 21 CFR820.30. General knowledge from the field of Project Management will be conveyed from the perspective of engineering or science personnel in the industrial medical field, particularlywith regard to FDA Quality System Regulations (QSR), ISO 13485 guidelines, and Good Clinical Practices (GCP's) for running clinical trials. Students will also take part in practical problem solving simulations based on real-world examples of medical device project anomalies. The combination of specialized project management knowledge for a heavily regulated area and realistic classroom simulation will provide a basis for those interested in commercial medical device development.