Quality Management Systems for Biomedical Engineers

3 credits · Graduate

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