Program Overview

Program Overview

The university program provides a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and process development best practices.

Course Details

Course Description

This course enables students to successfully engage within medical device product development teams in an industry setting, scope efforts appropriately, and reduce compliance risks. The course focuses on identifying best practices to address the relationship between product design and process development.

Course Objectives

• Identify best practices to address requirements for product design and process development
  • Develop a product design and perform risk management activities
  • Design validation and verification activities
  • Design transfer to manufacturing
  • Establish a controlled manufacturing process

Course Format

• Duration: As few as 11 weeks
• Units: 4.0
• Current Formats: Online
• Cost: Starting at $1,100.00

Course Schedule

Spring 2026 Schedule

• Date: March 30 - June 14
• Format: Online
• Instructor: David Law
• Fee: $1,100.00

Notes

• Enrollment limited; early enrollment advised.
• Enrollment deadline: April 5
• Deadline for refunds: February 02, 2026 to April 12, 2026

Course Requirements

• Book: The Certified Quality Engineer Handbook by Borror, Connie M.
• Book: Validation For Medical Device and Diagnostics Manufacturers by DeSain, Carol V.; Sutton, Charmaine V
• Internet access required to retrieve course materials.

Program Applications

Medical Device Engineering Certificate

This course applies toward the Medical Device Engineering certificate, which master's the fundamentals of medical device engineering, including design, manufacturing, quality control, and regulatory requirements. Format: Online.