Medical Device Firmware QA System

Overview

This system provides comprehensive testing for CPAP device firmware, ensuring compliance with medical device regulations and safety standards. It combines firmware validation with operational safety testing.

Features

Core Functionality

• Firmware update simulation and validation
• Power failure resilience testing
• Automated rollback mechanisms
• Checksum validation for firmware integrity

Safety Testing

• Pressure control validation (ISO 80601-2-70)
• Alarm threshold testing
• Fault injection capabilities
• Regulatory requirement traceability

Compliance Standards

The system supports validation for:

• IEC 62304 (Medical Device Software)
• ISO 13485 (Quality Management)
• FDA 21 CFR Part 820
• ISO 80601-2-70 (CPAP specific requirements)

System Architecture

Components

1. Firmware Management

   • Update simulation
   • Integrity validation
   • Rollback mechanisms

2. Safety Validation

   • Pressure control testing
   • Alarm response testing
   • Fault injection

3. Monitoring & Reporting

   • InfluxDB logging
   • Grafana dashboards
   • Jenkins CI integration

Usage

Running Tests

robot tests/firmware_update_test.robot
robot tests/safety_validation_test.robot