Quality Systems, Risk Management, & Regulatory Structures II

2 credits · College of Engineering catalogue

Advisory Prerequisite: Background in engineering or a physical science, including familiarity with engineering design processes . Enforced Prerequisite: BIOMEDE 653; No OP P/F; and graduate standing. Minimum grade requirement of “B” for enforced prerequisite. (2 credits) Current concepts and regulations in quality management systems, risk management, and regulatory structures impacting medical product development. Continuation of Qual Risk Reg I from the Fall term.