AI Assistant app Overview

AI Assistant app for Medical Device Regulatory Affairs, Quality Assurance, and R&D professionals.

The AI Assistant app empowers medtech professionals to work more efficiently and consider factors from hundreds of thousands of data points, promoting a data-driven approach to premarket regulatory compliance and post market surveillance.

We invite all community members to contribute to this wiki! It's a space created for everyone using the AI Assistant to share helpful resources. Your contributions will enhance the quality, reliability, and collaboration among users, benefiting us all.

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

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 (AI-Complaints-Assistant):

• 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.
• Clear explanations for reportability estimations, referencing the specific data points used in the predictive reportability evaluation.
• Real-time and batch processing assists with immediate complaint intake processing and retrospective analysis of old complaint data.

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.
• 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.

Documentation Templates (AI-Documentation-Assistant):

• Create documentation templates for medical device files containing guidance information.
• Improve team efficiency and promote consistency within the medical device files.
• Assistance with identifying required content based on applicable regulations and state-of-the-art standards.
• Content guidance based on well established quality standards and regulations such as FDA cGMP, ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366, IEC 60601 series, ISO 15223-1, ISO 10993 series, ISO 14155, IEC 81001-5-1, and EU MDR/IVDR

Note: New capabilities of the AI Assistant app will be published here as they become available.

Email [email protected] for inquiries about creating a custom AI Assistant app version.