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Test Execution, Not Documentation
FDA QMSR Compliant
RTLS Solutions for
Medical Device Manufacturers
Purpose-built tracking solutions that meet FDA 21 CFR Part 820, ISO
13485, and QMSR compliance requirements
while delivering measurable ROI.
QMSR Compliance Readiness Countdown
Built for FDA Compliance
Our RTLS solutions are designed from the ground up to meet the stringent regulatory requirements that medical device manufacturers face daily.
FDA evaluates Part 820 requirements under QMSR, focusing on traceability and control across design and production.
- Design History File (DHF)
- Medical Device File (MDF)
- Electronic Device History Record
Quality Management System Regulation compliance, ensuring your tracking systems align with the new harmonized requirements.
- Risk-Based Approach
- Process Validation
- Management Responsibility
International standard for medical device quality management systems with real-time documentation and audit trails.
- Document Control
- Traceability Requirements
- Process Approach
Electronic records and signatures compliance with secure audit trails and validated computer systems.
- Electronic Signatures
- Audit Trail
- System Validation
How Real-Time Data Powers Your
Quality System
Execution data integrates with existing workflows to support FDA-ready documentation and control.
QMS Integrations
FDA Documentation Outputs
RTLS for Medical Device Manufacturing Operations
LocaXion enables precise location tracking across regulated medical device environments, including clean rooms, labs, and shipping docks.
Success Stories from Industry Leaders
See how leading medical device manufacturers achieved FDA compliance and operational excellence with LocaXion RTLS.
Manual tracking of surgical instrument trays led to a 15% loss rate and FDA 483 observations for inadequate traceability.
Deployed UWB-based RTLS across 3 manufacturing facilities with full QMS integration.
“LocaXion transformed our instrument tracking from a compliance liability into a competitive advantage. Our FDA auditors were impressed with the real-time traceability.”
Complex multi-site production required better WIP visibility and DHR documentation for Class III devices.
Implemented hybrid BLE/UWB tracking with automated DHR population and real-time production dashboards.
“The integration with our MasterControl QMS was seamless. We now have complete visibility into every component's journey through production.”
Large-scale equipment assembly required precise tool tracking and calibration compliance across 500+ instruments.
Deployed SLAM-based tracking for mobile equipment and UWB for fixed assets with calibration alerting.
“Before LocaXion, we spent hours locating calibrated tools. Now our technicians have instant visibility, and our quality records are bulletproof.”
ROI That Speaks for Itself
Real operational outcomes observed by medical device manufacturers preparing for FDA QMSR inspections.
“LocaXion's RTLS solution transformed our FDA audit preparation from weeks to hours. The real-time traceability has become essential to our quality system.”
Ready to Achieve FDA
Compliance?
Schedule a compliance review with our medical device manufacturing experts. We'll assess your current tracking infrastructure and show you how RTLS can strengthen your quality system.