From AI Assistant App

App Files

Application executable: Media:

Reference file: Media: openFDA device_search_fields.xlsx

Reference file: Media: openFDA recall_search_fields.xlsx

See the sample files page for example settings and reports.

Sample Files: AI-Risk-Assistant

App Description

App Use Case: 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.

App Functionality: The AI-Risk-Assistant is designed to process product risk information, which may include details such as device models, usage settings, product codes/registrations, and other pertinent data. A Settings file contains the specific MAUDE and Recalls database query parameters as well as the AI prompts to process the data and identify hidden patterns and insights. With this information, the retrieval augmented generation model correlates the MAUDE and Recalls data sets and maps this information in a table format for easy consumption in risk management processes, such as hazard analyses, FMEAs (Failure Mode Effects Analysis) and other tools. The correlation is influenced by product codes, problem codes, specific malfunctions, use errors, root causes and reasons for recall, among other factors found in the data set and specified in the Settings file.

Diagram outlining the processing steps of the Risk Assistant:

An Excel document is generated containing results detailing the top product problems, along with additional analytics for each product problem including correlated produce recalls. It also includes the correlation information and hidden patterns in the MAUDE and Recalls data.