Medical Product Development

Catalog description

This course provides students with medical device development requirements and processes. The course is to be taken in conjunction with PL ET 481 as both courses will utilize a semester project to invent and design a new product. Over the course of the semester students will review the FDA classifications, filing requirements, and recommended practices for medical device development. This knowledge will be applied and practiced through the semester projects. Students will learn techniques for Failure Modes and Effects Analysis and how to properly document and manage product change through the development process. PL ET 482 Medical Product Development (1) This course provides students with medical device development requirements and processes. The course is to be taken in conjunction with PL ET 481 as both courses will utilize a semester project to invent and design a new product. Over the course of the semester students will review the FDA classifications, filing requirements, and recommended practices for medical device development. This knowledge will be applied and practiced through the semester project.Students will learn techniques for Failure Modes and Effects Analysis and how to properly document and manage product change through the development process.