In MedTech, a resilient, compliant supply chain is crucial for timely delivery, regulatory compliance, and patient safety. At Qualentra Global, we provide tailored supply chain management services for medical device companies, ensuring traceability, risk reduction, and operational efficiency in line with ISO 13485 and global standards.
- Supplier Qualification & Auditing
- Procurement & Component Traceability
- Inventory & Warehouse Management Strategy
- Cold Chain & Sterile Logistics Planning
- Regulatory-Compliant Documentation Flow
- Demand Forecasting & Distribution Optimization
End-to-End Lifecycle – 6 Stages of Supply Chain Management
Supply Chain Planning & Risk Assessment
Define sourcing strategies, identify bottlenecks, and build risk-resilient frameworks.
Supplier Evaluation & Onboarding
Audit and qualify suppliers to ensure alignment with quality, regulatory, and performance expectations.
Procurement & Inventory Setup
Optimize component selection, ensure lot traceability, and align inventory models with regulatory norms.
Logistics & Warehousing
Plan and implement logistics workflows including sterile packaging, cold chain, and storage protocols.
Distribution & Regulatory Coordination
Align distribution processes with country-specific regulations, UDI systems, and customs compliance.
Monitoring, Reporting & Optimization
Continuously monitor performance, address deviations, and optimize supply operations for scalability.
30%
Reduction in Lead Times
100%
Traceability Achieved
40%
Fewer Supply Chain Disruptions
Frequently asked questions
Traceability ensures that every component and process in your device's lifecycle is documented, which is vital for recalls, quality audits, and regulatory compliance.
Yes, we support global supplier management, including compliance with FDA, MDR, and ISO 13485 requirements across borders.
Absolutely. We plan and validate cold chain solutions in collaboration with our logistics partners to ensure product integrity throughout transit.