Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.
This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.
Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com
