PostMarket360

Abstract

PostMarket-360 is a validated platform for post-market surveillance, supporting both Adverse Events and Safety Recall data across regulatory sources.

This paper focuses on the Adverse Events capability using the FDA MAUDE database. The platform automates data retrieval, processing, and reporting to support regulatory activities such as PSUR, safety reviews, and trend analysis, while maintaining data integrity through a secure, read-only approach. Automated FDA MAUDE retrieval and analytical reporting.

1. Introduction

The platform provides the comprehensive configuration required for the validated operation of medical device vigilance. The current implementation focuses on the automated retrieval of adverse event reactions. All configurations are designed to comply with global data-integrity requirements, including GxP, 21 CFR Part 11, HIPAA, and GDPR. The architecture utilizes dedicated application and storage layers to maintain a secure, restricted-access environment, ensuring all data retrieval is conducted over encrypted outbound connections.

2. Solution Overview

PostMarket-360 provides a structured and automated approach to retrieving and processing adverse event data from the FDA MAUDE database.

The platform enables users to perform both standard and advanced searches, allowing precise filtering based on multiple parameters. Retrieved data is standardized and transformed into structured outputs for analysis and reporting.

A controlled, read-only data flow ensures accuracy, consistency, and full traceability across the process.

3. Business Impact

The implementation of PostMarket-360 streamlines regulatory compliance by automating complex reporting tasks and ensuring reliable data availability:

• Efficiency Gains: Faster data retrieval and report generation
• Improved Accuracy: Reduced manual errors
• Better Insights: Advanced search enables deeper analysis
• Audit Readiness: Ensures traceability and compliance

4. Product Objectives

• Simplify Data Retrieval: Enable quick and efficient extraction of adverse event data from the FDA MAUDE database
• Support Advanced Search: Allow users to perform refined searches using multiple parameters for precise results
• Ensure Data Integrity: Maintain accuracy by using a secure, read-only data retrieval process
• Improve Reporting Efficiency: Generate structured, ready-to-use reports for safety analysis and regulatory needs

5. Process Architecture and Flow

5.1 Architecture Layers

• User Interaction: Users engage with a Form to define primary and optional parameters. These inputs are validated before the system initiates the retrieval process.
• Data Retrieval: The system fetches the relevant manufacturer models and data points directly from the regulatory source.
• Data Transformation: The internal logic compiles the raw data, extracts required delimiters, and structures the information into functional Excel Pivot Tables.
• History & Insights: The system tracks search history to provide live insights and summaries, ensuring that every search is traceable and reproducible.

Hosted on high-performance server platforms such as Windows Server or Ubuntu. The platform is built on a modern, reliable stack optimized for enterprise performance & security.

6. Technology Stack

• Runtime environments: Powered by Node.js and Python intelligence services.
• Database Management: Utilizes MySQL for tracking metrics and system configurations.
• Infrastructure System Stability: Maintains dedicated resources to ensure enterprise-grade reliability and performance.
• Security: Employs encrypted outbound HTTPS for portal interactions while strictly restricting unauthorized access.