Lifecycle of the Clinical Product
General
Prefix
ACR
Course Number
622
Course Level
Graduate
Instruction Mode
Lecture
Department/Unit(s)
College/School
College of Science and Engineering
Description
Phases of the medical-product-development life cycle.
Credits
Min
2
Max
2
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Introduction to Quality Management Systems (ISO 13485).
Outcome
Ability to define the various phases of a medical product development life cycle and identify primary deliverables for each phase.
Outcome
Define cross-functional roles within a product development team and major responsibilities.
Outcome
Specify clinical roles, responsibilities, and deliverables within each of the phases of development.
Outcome
Demonstrate understanding of the risk mitigation processes and ability to perform a basic clinical effects analysis.
Outcome
Define the various sources of performance and safety information that are developed during product development and identify how to utilize this information.
Outcome
Reflect on the current product development climate including regulatory reform, comparative effectiveness research, and the reimbursement environment.
Outcome
Through participation in case studies, assignments and projects, acquire relevant practical experience in making contributions as a clinical professional for new products being developed.