RGA 6640 — Risk Management: Compliance and Processes
3 semester hoursGraduateLecture
Examines risk management practices and their impact on patient safety, product quality, and clinical effectiveness. Discussions include analysis of medical device risk management guidance documents, how medical device companies strive to ensure compliance, the responsibilities of regulatory professionals in risk management systems, and regulatory issues stemming from poor supplier performance and management. Evaluates risk management systems as they relate to particular categories of biomedical products manufactured in specific contexts, using case-based investigations and real-world examples. Offers students an opportunity to obtain the skills and knowledge they need to customize effective risk management methods within various global settings.