Applying Medical Device Industry Standards to Engineering Medical Device Course

The design of medical devices can serve as an intense learning opportunity for engineering students.Topics include various engineering disciplines, project management, design ethics, and using industry-based performance standards.This paper discusses the embedding of ISO 13485-1, Medical devices -Quality Management Systems; 21 CFR 820:30, Medical Device Quality Systems and Design Controls; ISO 14971-2019, Medical devices -Application of Risk Management to Medical Devices and ISO 10993-1, Biocompatibility in Medical Devices.The course is co-instructed between David Chen, Professor of Practice and Dr. Eileen Cadel, Adjunct Faculty who together guide the integration of regulatory material with UVA BME curricular objectives.The pedagogy employs case studies, in-class assessments, outside-class assignments, and team project-based learning.As a final course capstone, students submit a mock Pre-Submission (https://www.fda.gov/regulatory