Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. By collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru’s efforts benefit both students and staff.

Today’s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has made him a better educator for BME students.





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Some of the highlights of the show include:

  • Students were told what to do, not taught why to control quality, design, or risk. Greenlight Guru solidifies their understanding of the concept to make that connection.
  • The Risk Matrix is used to teach BME students which design controls need to be added to manage different levels of risk.
  • Devin appreciates the Design Control Matrix because it captures user needs through validation.
  • It’s difficult to teach the subtleties of the design and document control process, along with what some people consider unrelated links, such as risk.
  • Using a spreadsheet for traceability caused problems for Greenlight Guru’s 510(k)s. It was the driving force behind the creation of Greenlight Guru’s Traceability Matrix.
  • University students create a perfect test environment. If a concept isn’t clearly explained, then implementing it in the classroom will be a complete disaster.
  • Students, and those who hire them, are impressed by their ability to articulate an understanding of quality systems, regulatory affairs, and risk assessment.



Devin Hubbard

FDA’s Waterfall Diagram

Episode 61: Helping Prepare Biomedical Engineers Entering the Workforce

Andrew DiMeo

FDA Premarket Notification 510(k)

MedTech True Quality Stories Podcast

Greenlight Guru



“It’s really important for biomedical professionals to be knowledgeable, and maybe even somewhat proficient, with what a quality system is, what a regulatory strategy is...” Jon Speer

“Working with Greenlight and using the software really allows teaching the regulatory and risk analysis assessment and quality systems a lot easier.” Devin Hubbard 

“University students are just a perfect test environment. They’ll break it really quickly, and I don’t mean that as a bad thing.” Devin Hubbard 

“I always describe risk and design control - they’re really the same coin, there just two different sides.” Jon Speer



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