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The assessment and management of risk lie at the heart of medical device development, market clearance or approval, and postmarket evaluation. Two of the most critical yet challenging aspects of risk management are the establishment of acceptable risk and the coordination, analysis, and appropriate utilization of new data from various sources throughout the product life cycle.
Recorded February 23-24, 2016, this conference brought together a diverse group of industry and FDA experts to address these challenges and to share strategies and best practices. What tools and critical thinking processes go into establishing risk acceptability, and how might the acceptable level of risk need to be modified in light of new information? How are engineering, clinical, business, and other perspectives on risk consolidated to yield a meaningful estimation of real world patient benefits and harm? How are diverse sets of new information from various sources best communicated and used throughout quality and other company silos and disciplines? What are the best approaches for risk management with legacy products or systems? And where does the risk management typically fail, and how can one avoid common mistakes?
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