Compliant Medical Device QA Operations
Built for medical device manufacturers. Ensure FDA 21 CFR Part 820 compliance, maintain ISO 13485 certification, and achieve complete device history record automation with confidence.
BrixIQ Solutions for Medical Devices
Purpose-built features that understand the critical nature of medical device quality and regulatory compliance.
FDA QSR Compliance System
Complete quality system that ensures FDA 21 CFR Part 820 compliance with automated design controls, risk management, and validation workflows.
- Automated design control documentation
- Risk management workflows
- Validation and verification tracking
ISO 13485 Documentation Hub
Centralized document management that maintains ISO 13485 compliance with automated version control and change management.
- Document control and versioning
- Change control workflows
- Training record management
Device History Record (DHR) Tracking
Complete production history tracking for every device unit with automated DHR generation and batch documentation.
- Automated DHR creation
- Component traceability
- Production record management
Post-Market Surveillance Platform
Comprehensive CAPA management and adverse event tracking with automated reporting to regulatory authorities.
- Adverse event reporting
- CAPA workflow automation
- Post-market data analysis
Built for Medical Device Standards
BrixIQ understands the complex regulations and standards required in medical device manufacturing.
Design Controls & Risk Management
BrixIQ provides comprehensive design control workflows and risk management tools specifically designed for medical device development.
Design Controls
Complete design control workflows from design planning through design transfer with automated V&V documentation.
Risk Management
ISO 14971 compliant risk management with automated risk analysis, mitigation tracking, and post-market risk evaluation.
CAPA Management
Comprehensive corrective and preventive action system with root cause analysis and effectiveness verification.
Ready to Streamline Your Medical Device QA?
Join leading medical device manufacturers who trust BrixIQ for regulatory compliance and quality excellence.
15-minute personalized demo • No commitment required • FDA 21 CFR Part 820 & ISO 13485 compliant