Audit-Ready Operations from Lab to Patient
Eliminate the regulatory risk of fragmented supply chain and quality data. Better Data provides 100% traceability for medical device manufacturers, ensuring compliance and precision response at scale.
The Regulatory Risk of
Fragmented Operations
Manual Traceability Nightmares
Relying on disparate systems for UDI tracking leads to error-prone manual reconciliations that fail under audit pressure.
Recall Execution Lag
Without a unified data layer, identifying and isolating affected lots across global distribution takes days, not minutes.
Quality Data Silos
Manufacturing data, CAPA logs, and post-market surveillance live in vacuum, preventing proactive risk identification.
The CCO Operating Loop for MedTech
Transform high-compliance operations from a cost center into a competitive advantage with a unified loop of data and action.
Sense
Real-time telemetry from production lines, sterilization units, and supply chain endpoints.
Decide
Risk-based quality management and automated compliance checking across every lot.
Execute
Precision recall execution and automated field inventory optimization for surgical kits.
Govern
Immutable audit trails and automated UDI reporting for FDA, EMA, and global bodies.
Improve
Post-market surveillance and R&D feedback loops driven by real-world performance data.
Pillar Applications
The core modules that power-traceable, high-efficiency medical device operations.
Digital Quality Management
Automate CAPA, NC, and change control processes with cross-functional visibility and real-time status tracking.
UDI Asset Lifecycle
End-to-end tracking of durable and implantable devices from raw materials to patient implantation.
Automated Post-Market Surveillance
Ingest and analyze complaint data and adverse event reports to identify trends before regulators do.
Operational Success
Recall Orchestration
"Recall execution time reduced from 72 hours to 45 minutes."
Fleet Maintenance
"Predictive maintenance saved $2.4M in field service costs per unit year."
Supply Chain Integrity
"100% components traceability for audit compliance with zero manual hours."
Future-Proof Your MedTech Operations
Don't wait for the next audit to discover your data silos. Join the leaders building the future of medical device excellence on Better Data.