AI Assistant app Overview

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

Here's a breakdown of the AI Assistant app key functionalities:

Trend Analysis and Reports (AI-Analysis-Assistant):

Search through various datasets, such as medical journals, warning letters, SOTA standards, adverse event reports, and regulatory filings.
Gather information from a wide range of sources, such as local files, network drives, user interface, websites, openFDA databases, other public APIs.
Natural Language Processing (NLP) to formulate search queries intuitively.
Run powerful correlation analysis across different data categories, identifying trends and patterns about device safety and performance.
Save and track collected data for in-depth analysis and create reports in various formats including PDF, Word, CSV, XLS, and JPEG.

Complaint Reportability Estimation (AI-Complaints-Assistant):

Enter complaints through the user interface or upload them directly from Word or PDF files (local or network).
NLP-powered reportability assessment will estimate the reportability of a complaint based on pre-configured criteria and NLP analysis..
Clear explanations for reportability estimations, referencing the specific data points used in the evaluation.
Real-time and Batch Processing supports both immediate complaint intake processing and retrospective analysis of old complaint data.

Risk Assessment Assistant (AI-Risk-Assistant):

Extract targeted data from diverse data sources to uncover hidden insights about hazards 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 Benefit-Risk Analysis ensuring a clear understanding of potential advantages and drawbacks.
Assistance with product safety update reports, clinical evaluation plans, and regulatory submissions with greater efficiency.
Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks.

This AI assistant empowers RA and QA professionals to work more efficiently considering hundreds of thousands of data points and promoting a data-driven approach to premarket regulatory compliance and post market surveillance.

Getting started

AI-Analysis-Assistant
AI-Complaints-Assistant
AI-Risk-Assistant