AI Assistant app Overview

AI Assistant app for Medical Device Regulatory Affairs and Quality Assurance.

The AI Assistant app offers a comprehensive suite of tools to streamline Regulatory Affairs and Quality Assurance processes for medical device companies. Here's a breakdown of its key functionalities:

• • Trend Analysis and Reports (AI Reporting Assistant):**

• **Personalized Search:** Effortlessly search through various datasets relevant to medical devices, including medical journals, warning letters, adverse event reports, and regulatory filings.
• **Customizable Data Sources:** Gather information from a wide range of sources, including local files, network drives, user interfaces, websites, openFDA APIs, CDC APIs, and more.
• **Natural Language Processing (NLP):** Utilize Google Gemini LLM to formulate search queries using natural language, making the process intuitive.
• **Data Correlation:** Run powerful correlation analysis across different data categories, identifying potential trends and patterns within medical device safety and performance.
• **Data Tracking and Reporting:** Save and track collected data for in-depth trend analysis and generate reports in various formats like PDF, Word, CSV, XLS, and JPEG.

• • Complaint Reportability Estimation (AI Complaints Assistant):**

• **Effortless Complaint Input:** Submit complaints through the user interface (UI) or upload them directly from Word or PDF files (local or network).
• **NLP-powered Reportability Index:** The AI estimates the reportability of a complaint based on pre-configured criteria and NLP analysis, helping determine if an FDA Form 3500 needs to be submitted.
• **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.
• **Flexible Output:** View the reportability assessment with reasoning on the UI or export it to supported file formats.

• • Risk Assessment Assistant (AI Risk Assistant):**

• **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.
• **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.
• **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.

Getting started

• AI Reporting Assistant
• AI Complaints Assistant
• AI Risk Assistant