Software Quality & FDA Compliance: Comprehensive Testing
Triophore ensured LifeSignals Inc.'s software met FDA 510(k) compliance through comprehensive Unit and E2E Testing.
The Challenge
Business Problem
LifeSignals Inc. needed to perform comprehensive Unit and E2E Testing on their entire software to meet the stringent requirements of the FDA 510(k) submission, ensuring the software's safety, efficacy, and reliability.
The Goal
Achieve FDA 510(k) clearance through rigorous software validation and demonstrate the software's safety, efficacy, and reliability.
Technology Stack
Frontend
Backend
The Solution
Discovery & Architecture
Triophore began by analyzing LifeSignals' software architecture and regulatory requirements to create a detailed testing strategy. The architecture involved multiple components including the ECG patch, mobile app, backend services, and cloud infrastructure. The discovery phase focused on understanding the data flow and interactions between these components to design effective test cases.
Development Phase
Triophore implemented a comprehensive testing regimen that included both Unit and E2E testing. E2E testing simulated real-world user scenarios to validate the entire application flow across all integrated components, ensuring device connectivity, data acquisition, and real-time data display. Unit testing focused on validating individual software components in isolation to ensure each piece of code worked correctly. Detailed reports were generated to document test plans, test cases, execution results, identified bugs, and bug fixes.
Key Feature Implementation
Comprehensive E2E Testing, Rigorous Unit Testing, Detailed Test Reporting Aligned with FDA Guidelines, Validation of Device Connectivity and Data Acquisition, Real-time Data Display Validation
The Results
Performance
Improved software performance through identification and resolution of defects during testing.
Scalability
Ensured scalability of the backend services by simulating high volumes of data traffic using JMeter.
User Impact
Enhanced user safety and confidence in the reliability of the medical device software.
Business Efficiency
Streamlined FDA 510(k) submission process with comprehensive testing documentation.