Medical Device Monitoring
FDA 21 CFR Part 820 and ISO 13485 compliant environmental monitoring for medical device manufacturing, cleanrooms, and storage facilities.
Quality-Focused Monitoring
ATEK delivers environmental monitoring solutions designed for the rigorous quality requirements of medical device manufacturing. Our platform ensures regulatory compliance while providing real-time visibility into critical production environments.
From cleanrooms to warehouses, ATEK's sensors and cloud platform continuously monitor environmental conditions critical to device quality and patient safety.
- FDA 21 CFR Part 820 QSR compliance
- ISO 13485 quality management support
- ISO 14644 cleanroom classification
- Complete audit trail documentation
- Electronic records with data integrity
- Validated monitoring systems
Applications
Monitoring solutions for medical device operations
Manufacturing
Monitor cleanrooms and controlled environments during medical device production.
Sterilization
Track environmental conditions in sterilization areas and storage facilities.
Warehousing
Ensure proper storage conditions for finished devices and components.
R&D Labs
Environmental monitoring for device testing and development laboratories.
Frequently Asked Questions
How does ATEK support FDA QSR compliance?
ATEK provides validated environmental monitoring with complete audit trails, electronic records, and documentation required for FDA 21 CFR Part 820 Quality System Regulation compliance in medical device manufacturing.
Can ATEK monitor cleanrooms for ISO 13485?
Yes, ATEK monitors temperature, humidity, differential pressure, and particle counts in ISO classified cleanrooms. Our system provides the documentation and traceability required for ISO 13485 certification.
What parameters can ATEK monitor in device manufacturing?
ATEK monitors temperature, humidity, differential pressure, CO2, and integrates with particle counters for comprehensive cleanroom monitoring. All data is logged continuously with real-time alerts.
Does ATEK provide validation documentation?
Yes, ATEK provides IQ/OQ/PQ validation protocols, system validation documentation, and ongoing support for FDA audits and ISO certification assessments.
Ensure Quality in Device Manufacturing
Get a personalized demo and see how ATEK can help ensure compliance and protect your device quality.