{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F723ffb30-d5bb-4c04-9c85-d5b61d06c61e","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Greenlight Guru In the Classroom: A University's Real-world Approach","description":"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. \n\nBy collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru\u2019s efforts benefit both students and staff. \n\nToday\u2019s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has made him a better educator for BME students. \n\nSome of the highlights of the show include:\n \n\u25cf\tStudents 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. \n\u25cf\tThe Risk Matrix is used to teach BME students which design controls need to be added to manage different levels of risk.\n\u25cf\tDevin appreciates the Design Control Matrix because it captures user needs through validation. \n\u25cf\tIt\u2019s difficult to teach the subtleties of the design and document control process, along with what some people consider unrelated links, such as risk. \n\u25cf\tUsing a spreadsheet for traceability caused problems for Greenlight Guru\u2019s 510(k)s. It was the driving force behind the creation of Greenlight Guru\u2019s Traceability Matrix. \n\u25cf\tUniversity students create a perfect test environment. If a concept isn\u2019t clearly explained, then implementing it in the classroom will be a complete disaster.\n\u25cf\tStudents, and those who hire them, are impressed by their ability to articulate an understanding of quality systems, regulatory affairs, and risk assessment.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/75754a6e-4c9a-4f72-ab16-8202dd413078/c238e6ad-5fcb-4f9e-8d7e-f851d4483dad.jpg"}