AI-Risk-Assistant: Difference between revisions

The AI-Risk-Assistant collects and analyzes vast amounts of data from diverse sources to pinpoint safety trends and device issues, enabling proactive risk mitigation in premarket and post market risk management activities (e.g., PMS - post market surveillance). Utilizing AI capabilities, and access to abundant public data such as Recalls Enforcement and MAUDE data (courtesy of FDA), the Risk Assistant offers powerful tools to see the bigger picture and make better informed decisions. The Risk-Assistant easily consolidates key problems and potential harms associated with specific product codes, brands, or multiple devices under the same regulation, and presents those hidden insights and data patterns in an easy-to-understand format. This aids the risk management professional in balancing risks against benefits, and adopting a quantitative, data-driven approach, free from biases.