Description
Most medical device manufacturers use FMEA as a part of their risk management system. Risk Management is required by ISO 13485 and risk analysis by the FDA`s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices". The FMEA tool is used to provide an understanding of risk management and risk analysis techniques and methodologies, and to develop the skills required to apply these methodologies appropriate to a particular product. Risk management and analysis is considered throughout the entire life-cycle of the product, in design, production and distribution processes. The use of FMEA (Failure Mode and Effects Analysis) in identifying hazards, their severity, the probability that they might occur and the probability of preventing/detecting the hazard. are considered. Control measures and the monitoring of the effectiveness of such controls are discussed.
The presentation will also discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.
