Risk Management for Medical Devices

The safety and risk management of medical devices are becoming ever more important issues to be addressed by manufacturers. In addition, postmarket surveillance (PMS) and vigilance are very significant elements of risk management. What effect will the review of the Medical Device Directives have on risk management and analysis? Standards change, expectations increase, and information is now more available and transparent. The recent increase in FDA product recalls highlights the necessity to have an established risk management system in place. This interactive seminar will look at the risk management standard, product liability, biological safety, and PMS, and will also provide a detailed practical opportunity to learn the various ways in which a risk analysis may be performed. Understanding how to manage risk is paramount to the success of a medical device company.