— Manufacturing Readiness, Optimization & Post Market Support

Prerequisites & course information

Course Description: Manufacturing readiness strategies employed in the medical device and life science industries, including contract manufacturing. Tools to reduce manufacturing waste and variation, including Lean Six Sigma. Regulatory requirements for quality assurance through quality management systems. Post-market activities including complaint investigation and reporting, FMEA impacts, clinical trial support and closure, and product obsolescence. Learning Activities: Lecture 3 hour(s). Enrollment Restriction(s): Open to Medical Device Development majors only. Grade Mode: Letter. Learning Activities: Lecture 3 hour(s). Enrollment Restriction(s): Open to Medical Device Development majors only. Grade Mode: Letter.