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AI Assistant app Overview: Difference between revisions
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* Save and track collected data for in-depth analysis and create reports in various formats including PDF, Word, CSV, XLS, and JPEG. | * Save and track collected data for in-depth analysis and create reports in various formats including PDF, Word, CSV, XLS, and JPEG. | ||
'''Complaint Reportability | '''Complaint Reportability (AI-Complaints-Assistant):''' | ||
* Enter complaints through the user interface or upload them directly from Word or PDF files (local or network). | * Enter complaints through the user interface or upload them directly from Word or PDF files (local or network). | ||
* AI-powered reportability assessment will estimate the reportability of a complaint based on pre-configured criteria and NLP analysis. | * AI-powered reportability assessment will estimate the reportability of a complaint based on pre-configured criteria and NLP analysis. | ||
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* Real-time and batch processing assists with immediate complaint intake processing and retrospective analysis of old complaint data. | * Real-time and batch processing assists with immediate complaint intake processing and retrospective analysis of old complaint data. | ||
'''Risk Assessment | '''Risk Assessment (AI-Risk-Assistant):''' | ||
* Extract data from disparate sources to uncover hidden insights about hazards and safety trends related to usability, manufacturing, design, and other key aspects. | * Extract data from disparate sources to uncover hidden insights about hazards and safety trends related to usability, manufacturing, design, and other key aspects. | ||
* Assistance with estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | * Assistance with estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | ||
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* Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | * Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | ||
'''Documentation | '''Documentation Templates (AI-Documentation-Assistant):''' | ||
* Create documentation templates for medical device files containing guidance information. | * Create documentation templates for medical device files containing guidance information. | ||
* Improve team efficiency and promote consistency within the medical device files. | * Improve team efficiency and promote consistency within the medical device files. | ||