Designed for engineers, technicians, and professionals focusing on product risk, this course teaches you the common risk-management methods used in product design. It also focuses on recently enacted standards specifically related to medical device risk management. Using case studies and interaction, you will practice identifying potential product hazards, FMEA, hazard and fault tree analysis, and all the critical skills needed to create a risk management process.
This course illustrates commonly used risk-identification and risk-reducing methods. It shares practical applications implementing several of the recently enacted standards relevant and applicable to medical device risk management, (ISO/EN 14971, risk as related to 21 CFR 820, risk as related to ISO 13485:2003, impacts of software risk assessment for ANSI/AMI SW68, impacts of software risk assessment for IEC 62304:2006, impacts of risk on human factors engineering IEC 62366) and to most other industries. Through examples, the instructor explains how to identify product and process hazards, evaluate the hazards for possible level of risk, and ways to creatively brainstorm on mitigating the risk.
Quality managers, engineers, and technicians involved in the development/manufacture of medical devices. Professionals directly involved in meeting FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of the quality system regulation, including direct work experience.