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.

Dates:

March 20, 2014

October 7, 2014