Logistics solutions for medical device manufacturers
Stay ahead of FDA and ISO documentation requirements across every shipment. Agistix gives medical device teams one platform for field service execution, loaner management, and reverse logistics.
From field service dispatch to regulatory documentation
UDI and lot-level shipment traceability
Device identifier, lot number, and serial number data carried through every shipment record.
- Captures UDI, lot number, and serial number data on every shipment record, giving quality and regulatory teams complete traceability across the distribution network
- When an FDA inspection or CAPA investigation requires shipment history, the record is already built and retrievable on demand
- Document automation generates packing lists, certificates of conformance, and customs documentation with device-level data populated from the shipment record
Loaner, demo, and consignment logistics
Outbound, in-use, and return cycles tracked from dispatch through redeployment.
- Manages the complete movement cycle for loaner instrument sets, demonstration equipment, and consignment inventory
- Shipment records track asset status from dispatch through return so field service and operations teams always know where every loaner or consignment unit is and when it is available
- Return workflows trigger automatically on delivery confirmation so receiving teams are prepared ahead of arrival
Capital equipment and installation logistics
Oversize and high-value shipment execution for imaging systems and diagnostic equipment.
- Connects to specialized carriers for white-glove and inside delivery of imaging systems, surgical robotics, and laboratory equipment
- Equipment serial numbers, installation addresses, and delivery window requirements carried on the shipment record
- Exception alerts surface delays before they affect scheduled installation windows
Reverse logistics for repair and return
RMA workflows and chain-of-custody documentation for repair, reprocessing, and field replacements.
- Routes inbound returns to the correct service center or reprocessing facility via RMA workflows
- Chain-of-custody documentation and proof of delivery captured on the return record, supporting CAPA workflows under 21 CFR Part 820 and ISO 13485
- Devices requiring sterilization carry status flags through the return cycle so quality and operations stay aligned
What our customers are saying
Agistix stands out for their exceptional support – their team is responsive, collaborative, and consistently goes above and beyond to ensure our success. Their partnership has made a measurable impact on our performance and service levels, and they truly exemplify what it means to be a trusted supply chain partner.
More to explore across the platform
The world is taking notice
See Agistix in action
Learn more about how Agistix supports medical device logistics from field service execution through regulatory documentation.
FAQs
Can Agistix track UDI and lot-level data for medical device shipments?
Yes. Agistix captures and carries UDI, lot number, and serial number data on every shipment record. When a regulatory inspection or CAPA investigation requires shipment history on a specific device or lot, the complete record including carrier events, documents, and delivery confirmation is retrievable on demand.
Can Agistix handle capital equipment installations for medical devices?
Yes. Agistix connects to specialized carriers for white-glove and inside delivery of imaging systems, surgical robots, and diagnostic capital equipment. Equipment serial numbers, installation addresses, and delivery window requirements are carried on the shipment record, with real-time status available to field service coordinators and the receiving facility simultaneously.
How does Agistix support reverse logistics and RMA workflows?
Agistix supports inbound returns for repair, reprocessing, and field replacements with RMA workflows that route devices to the correct service center. Chain-of-custody documentation and proof of delivery are captured on the return record, supporting CAPA and complaint handling workflows under 21 CFR Part 820 and ISO 13485.
How does Agistix handle temperature-sensitive medical device and IVD shipments?
Agistix supports temperature-controlled execution for in-vitro diagnostics, reagents, and other temperature-sensitive medical products across refrigerated and frozen carrier networks. IoT and telemetry integrations capture device-level temperature data, and excursion events are logged to the shipment record for quality review.
Does Agistix integrate with medical device ERP and quality management systems?
Yes. Agistix integrates with SAP, Oracle, Microsoft Dynamics, and other leading ERP and WMS platforms via REST API, EDI, and sFTP. Shipment execution data, documentation, and exception events flow bidirectionally to keep logistics records in sync with quality management and complaint handling systems.