Quality Management Systems for Biomedical Engineers

Description from DukeHub

The course establishes industry best-practice procedures and methods for the development of medical devices within a regulated environment such as that required by the FDA in 21CFR820. Specific key elements of a regulatory submission will be generated as the course progresses through elements of specification, risk management, verification and validation. Alongside understanding and exercising key principles of Quality Management as applied to both design & manufacture, students will also learn how to operate within typical industry systems and organizational structures. Area Designator: GE

Skills

• policy and lawdescription: "regulated" and 1 more

AI-resilient: 1 of 5 1/5

• No: Physical, lab or field work
• No: Live work with people
• ✓Yes: Judgment someone is accountable for · "risk"
• No: A craft you practice with your hands or body
• No: Small, in-person format

The checks lean on Microsoft Research, Working with AI (2025), which found generative AI applies least to physical work and hands-on work with people. A signal, not a promise. How the score works

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