Lifecycle of the Clinical Product

Introduction to Quality Management Systems (ISO 13485).

Ability to define the various phases of a medical product development life cycle and identify primary deliverables for each phase.

Define cross-functional roles within a product development team and major responsibilities.

Specify clinical roles, responsibilities, and deliverables within each of the phases of development.

Demonstrate understanding of the risk mitigation processes and ability to perform a basic clinical effects analysis.

Define the various sources of performance and safety information that are developed during product development and identify how to utilize this information.

Reflect on the current product development climate including regulatory reform, comparative effectiveness research, and the reimbursement environment.

Through participation in case studies, assignments and projects, acquire relevant practical experience in making contributions as a clinical professional for new products being developed.