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AI Assistant app Overview: Difference between revisions
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* Traceable Reasoning: The assistant provides clear explanations for its reportability estimations, referencing the specific data points and regulations used in the evaluation. | * Traceable Reasoning: The assistant provides clear explanations for its reportability estimations, referencing the specific data points and regulations used in the evaluation. | ||
* Real-time and Batch Processing: Supports both real-time analysis for immediate complaint intake processing and batch mode for retrospective analysis of existing complaint data. | * Real-time and Batch Processing: Supports both real-time analysis for immediate complaint intake processing and batch mode for retrospective analysis of existing complaint data. | ||
* Flexible Output: | * Flexible Output: View the reportability assessment with reasoning on the UI or export it to supported file formats. | ||
Risk Assessment Assistant (AI Risk Assistant): | Risk Assessment Assistant (AI Risk Assistant): | ||
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* Streamlined Data Mining: Extract targeted data from diverse sources, tailored to uncover crucial insights on common potential hazards related to usability, manufacturing, design, and other key areas. | * Streamlined Data Mining: Extract targeted data from diverse sources, tailored to uncover crucial insights on common potential hazards related to usability, manufacturing, design, and other key areas. | ||
* Probability Estimation: The AI assistant can assist in estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | * Probability Estimation: The AI assistant can assist in estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | ||
* Benefit-Risk Analysis Support: | * Benefit-Risk Analysis Support: Facilitate a comprehensive benefit-risk analysis for your medical device, ensuring a clear understanding of potential advantages and drawbacks. | ||
* Regulatory Support:** Generate product safety update reports, clinical evaluation plans, and regulatory submissions with greater efficiency. | * Regulatory Support:** Generate product safety update reports, clinical evaluation plans, and regulatory submissions with greater efficiency. | ||
* Risk Assessment Frameworks: | * Risk Assessment Frameworks: The assistant supports various risk assessment frameworks, including Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | ||
This AI assistant empowers medical device companies to work more efficiently in RA and QA activities, promoting a data-driven approach to ensure medical device safety and regulatory compliance. | This AI assistant empowers medical device companies to work more efficiently in RA and QA activities, promoting a data-driven approach to ensure medical device safety and regulatory compliance. | ||