Integrating Risk Management with the Quality System
|Event Date/Time: Sep 11, 2008|
Risk Management is intended to be a component of an overall Quality System during all phases of the lifecycle of a medical product. The purpose is to assure that the medical product is designed, manufactured, and distributed in such a manner that the customer receives the safest possible product. Risk Management recognizes that there is always some degree of risk in the use of a medical product, but the complete and successful integration of risk management in the quality system will result in a low risk product being delivered for use.
Areas Covered in the seminar:
* Previously, companies have considered risk in the design of medical devices through the use of FMEA, but have often failed to completely integrate the results of the risk process in the manufacturing and delivery process, and especially in the post-market phases, such as CAPA.
* Risk management throughout the quality system, including design, manufacturing, distribution and post-distribution.
* Successful application of risk management principles within quality procedures.