Quality Management Standards for Biomedical Engineers

Catalog description

This course is designed for biomedical engineering students who plan to work in industry with a focus on manufacturing quality systems The course covers industry related to Quality System Management with an emphasis on using an ISO 13485 based QMS. Topics will include: ISO 13485 requirements, including requirements for ISO 13485 documentation (i.e. quality objectives, quality manual, procedures, work instructions, quality system records, etc). Other topics will include planning, conducting, and documenting an internal audit. At the end of the course the students may earn a NCSU-IES certification as an ISO 13485 internal auditor.