Zero-error manufacturing for Class I, II, and III devices. Our EFM platform automates Device History Records (eDHR), UDI tracking, and CAPA workflows with sub-second precision.
Ensure perfect patient safety and regulatory compliance with manufacturing intelligence built for the med-tech industry.
Native eDHR automation that captures every torque value, inspection result, and signature for undisputed history.
Automated Unique Device Identification labeling and registry synchronization to prevent compliance gaps.
Integrated Corrective and Preventive Action workflows that trigger instantly when deviations are detected.
Full support for electronic records and signatures with multi-factor biometric validation at the station.
Total traceability from sterile packaging lot numbers to individual micro-component serials.
Pre-validated core modules and GAMP 5 documentation to accelerate your system rollout and validation cycle.
Our platform provides the micro-precision visibility required to manufacture life-saving devices with absolute confidence.
Eliminate the risk of illegible handwriting and manual entry errors forever.
Reduce audit response time from days to minutes with instant digital thread retrieval.
Identify manufacturing drift early to prevent expensive scrap of sterile components.
Navigating the Regulatory Future of Med-Tech
Our MES enforces scanning and validation of sterile packaging lot numbers and expiration dates before any device can be authorized for final release.
Yes. Our platform includes specific data structures for EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) technical documentation.
Absolutely. The system verifies that an operator's training is current for a specific operation before allowing them to sign off on a DHR task.
Join the elite med-tech manufacturers scaling their operations with Hackaback's Edge-First intelligence.
