Medical Device Manufacturer Achieves 100% FDA Compliance
How a Class II medical device manufacturer transformed their quality operations with BrixIQ's FDA-compliant platform, reducing audit preparation time by 85% and achieving complete design control compliance.
Key Results
Breakthrough improvements in FDA compliance and quality operations
Document Search Time
Customer Issue Response
FDA Audit Preparation
Risk Management Efficiency
Company Background
This 200-employee medical device manufacturer specializes in cardiovascular implants and diagnostic devices. As a Class II device manufacturer under FDA oversight, they must maintain strict compliance with 21 CFR Part 820 (Quality System Regulation) while managing complex design controls and risk management requirements.
With over 15 years in medical device manufacturing, they produce life-critical devices that require the highest levels of quality assurance, complete traceability, and rigorous post-market surveillance. Their products are used in hospitals worldwide, making regulatory compliance and patient safety their top priorities.
The Challenge
Before implementing BrixIQ, the company struggled with fragmented quality systems that made FDA compliance difficult and time-consuming, putting their ability to bring new devices to market at risk:
FDA design control documentation scattered across multiple systems with incomplete traceability
CAPA processes were manual and slow, causing regulatory compliance concerns
Risk management activities tracked in spreadsheets with no automated monitoring or alerts
Device History Records (DHR) creation required weeks of manual compilation for each production lot
Post-market surveillance data collection was fragmented and reactive rather than proactive
"FDA audits were our biggest stress point. We'd spend 6-8 weeks just gathering documentation that should have been at our fingertips. Our design controls were complete but scattered across so many systems that proving compliance was a nightmare. We knew we had good processes, but we couldn't demonstrate them effectively."
The BrixIQ Solution
BrixIQ provided a comprehensive FDA-compliant quality platform that unified their design controls, risk management, and CAPA processes into a single, audit-ready system:
Integrated design control platform with automated V&V documentation and traceability matrices
Streamlined CAPA workflows with automated root cause analysis and effectiveness verification
ISO 14971 compliant risk management system with real-time monitoring and alert capabilities
Automated DHR generation with complete component traceability and batch documentation
Comprehensive post-market surveillance platform with adverse event tracking and trending analysis
FDA Design Controls
Complete design control platform with automated V&V documentation, traceability matrices, and design history files that ensure 100% FDA 21 CFR Part 820 compliance with real-time audit readiness.
Risk Management
ISO 14971 compliant risk management with automated risk analysis workflows, mitigation tracking, and post-market risk evaluation that provides continuous visibility into device safety profiles.
Implementation Timeline
The implementation was completed in 4 weeks with full FDA validation and seamless integration to existing quality systems:
Week 1: Compliance Assessment
- FDA 21 CFR Part 820 gap analysis
- Design control documentation review
- Risk management process mapping
- CAPA workflow optimization planning
Week 2-3: System Configuration
- Design control workflow configuration
- Risk management database setup
- CAPA process automation implementation
- ERP integration for DHR automation
Week 4: Validation & Training
- System validation per FDA requirements
- Quality team training and certification
- Document migration and validation
- Go-live and performance monitoring
Results in Detail
FDA Audit Excellence
The transformation in FDA audit readiness was remarkable. What previously required 6-8 weeks of frantic documentation gathering now takes just 1 week of focused preparation, with all required documents instantly accessible and audit trails complete.
"Our most recent FDA inspection was the smoothest we've ever experienced. The inspector was impressed with our documentation completeness and real-time access to design controls. We received zero 483 observations for the first time."
Design Control Mastery
Achieving 100% design control compliance with automated V&V documentation and traceability matrices transformed their product development process from compliance burden to competitive advantage.
CAPA Process Revolution
Automated CAPA workflows with root cause analysis and effectiveness verification reduced resolution times by 73% while improving the quality of corrective actions and preventing recurrence.
- Automated root cause analysis with decision trees
- Real-time CAPA effectiveness monitoring
- Proactive trend analysis preventing recurrence
"BrixIQ transformed us from reactive compliance to proactive quality leadership. We now have complete confidence in our FDA readiness, our design controls are bulletproof, and our risk management is truly predictive. Most importantly, we can focus on innovation knowing our quality foundation is rock solid."
Ready to Master FDA Compliance?
See how BrixIQ can help your medical device operation achieve similar results.