Transform Your Workflow with AI-Powered Solutions: Streamline Compliance, Enhance Efficiency, and Make Data-Driven Decisions.
New apps are regularly being created, all of which you’ll have access to with your all-inclusive subscription and 24/7 support.
MAUDE Reporter
Make smarter decisions, faster.
This powerful app leverages AI to analyze massive FDA medical device data. Uncover hidden patterns, summarize safety trends, and gain real-world insights – all through natural language. Analyze complex data efficiently and make data-driven decisions with confidence.
Complaints Assistant
Utilize AI to automate complaint assessments and documentation, ensuring accurate reportability and compliance. Effortlessly manage data, generate detailed summaries, and make informed decisions with ease. Simplify your workflow and enhance efficiency with intelligent, user-friendly tools.
Risk Management
Leverage AI to analyze and assess risks efficiently. Visualize data trends, identify potential hazards, and implement mitigation strategies seamlessly. Enhance your decision-making process and ensure compliance with a user-friendly, intelligent tool designed to simplify risk management.
Technical Documentation
Utilize AI to streamline the creation and management of medical device technical documentation. Ensure regulatory compliance, organize essential documents, and generate reports effortlessly. Enhance your workflow and maintain thorough, accurate records with a user-friendly, intelligent tool designed to simplify design controls & compliance tasks.
Document Chat
Document Chat is an AI-powered tool for efficient research and literature review. The app reads and organizes PDF documents, allowing users to ask context-specific questions and receive instant, relevant answers. It displays responses on-screen and saves the Q&A interactions to a Word document for easy reference. With customizable settings for context and analysis, it streamlines the research process and supports effective document review.
510k Assistant
The 510(k) Assistant streamlines FDA submission preparation by automating eSTAR-compliant content creation. It extracts data from predicate device summaries, identifies similarities, and helps users input specific device details. The app generates customized submission forms, reducing administrative tasks while ensuring all regulatory requirements are met. Users can review and customize content for accuracy with its intuitive interface before final submission.
Watchdog Agent
Watchdog Assistant automates the process of gathering and analyzing online information to keep you informed about industry trends, regulatory changes, and competitor activity. By continuously monitoring specified websites, it uses intelligent algorithms to extract relevant data based on your criteria (keywords, dates, categories) and generates concise summaries of new information. Notifications are sent via email with summaries and original content attached for easy reference, ensuring you stay up-to-date and make informed decisions quickly.
Automation Agent
The Automation Assistant streamlines the management of AI Assistant apps by automating tasks on a set schedule. Users can configure tasks, set up automated schedules, and choose to receive notifications with results attached or summarized in the email body. The app also generates a Word document with an activity log for easy tracking of market data insights, safety trends, and other conditions. This tool simplifies the process of monitoring and reporting, making it easier to stay updated from anywhere.
Custom AI Agent
Your Custom AI Agent can alert you only when new information becomes available, ensuring you stay informed without unnecessary updates. By setting specific parameters, you can receive accurate, up-to-date reports one time or periodically, tailored to your needs. The AI pulls data from multiple sources for device classification, postmarket data, TPLC data, and more—combining the power of AI with automation to streamline decision-making and keep you focused on what matters most.