ACR622 - Lifecycle of the Clinical Product

General

Prefix

ACR

Course Number

622

Course Level

Graduate

Instruction Mode

Lecture

Description

Phases of the medical-product-development life cycle.

Prerequisites

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.

Course Outline

Dependencies