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AI-Complaint-Prompt-Assistant: Difference between revisions
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==App Description== | ==App Description== | ||
'''Use | '''App Use Case:''' | ||
The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency. | The AI-Complaints-Assistant streamlines complaint intake in call centers by using AI to apply a medical device reportability engine, which offers predictive scoring to determine if a complaint is reportable, sparing manual research of MAUDE records. It optimizes resource usage and prioritizes RA/QA review for timely MDR submissions by assessing the likelihood of FDA reportability based on MAUDE history, rather than just matching data. In addition it also creates pre-populated FDA Form 3500 forms for complaints with high reportability scores, to further expedite the process and improving efficiency. | ||
''' | '''App Functionality:''' | ||
The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file. | The AI-Complaints-Assistant is designed to accept complaint descriptions entered into a prompt, which may include natural language describing customer complaints and any relevant references to device models, usage settings, troubleshooting information, and other related details. Additionally, it reads a Settings file containing MAUDE query parameters, such as product problem codes, patient problems and outcomes, date ranges, and various other fields, along with prompts used for different processing steps in the similarity evaluation. The predictive reportability scores are influenced by factors such as the device problem code, patient problems and outcomes, the estimated severity of potential harm and other attributes specified in the Settings file. | ||