Device logistics with records you can defend
Lot-level and UDI traceability, chain-of-custody records and documented SOPs for medical device brands. Compliance-ready handling, six miles from San Diego.
What does medical device logistics require?
Medical devices demand traceability, controlled handling and defensible records. Lateral Fulfillment tracks inventory by lot and UDI, maintains chain-of-custody records and operates under documented SOPs, so distribution, returns and field actions can be evidenced. Handling is compliance-ready; the brand retains its own regulatory registrations.
Does Lateral Fulfillment hold medical device certifications?
No, and it does not claim to. Lateral Fulfillment provides capability-based, compliance-ready handling — documented SOPs, lot and UDI traceability, chain-of-custody and controlled storage — that a device manufacturer's own quality system can rely on. Regulatory registration and certification remain the manufacturer's responsibility.
Controls that hold up
Inventory traced by lot and unique device identifier.
Documented custody from receipt to dispatch.
Written procedures across every handling step.
Segregated, condition-appropriate storage.
Traceable returns and recall-ready records.
Procedure kits assembled under SOP control.
Frequently asked questions
Is Lateral Fulfillment certified for medical devices?
Lateral Fulfillment does not hold or claim medical device certifications. It provides compliance-ready handling — documented SOPs, lot and UDI traceability, chain-of-custody and controlled storage — that supports a manufacturer's own quality system. Certification and registration remain the manufacturer's responsibility.
How is traceability maintained for devices?
Inventory is tracked by lot and unique device identifier through the warehouse management system, with chain-of-custody records from receipt to dispatch. That makes distribution, returns and any field action traceable to specific units.
Can Lateral Fulfillment support a recall or field action?
Yes. Because units are traced by lot and UDI with custody records, affected inventory can be identified, quarantined and reported quickly. The records are designed to support the manufacturer's field-action process.
How are devices stored?
In segregated, condition-appropriate storage defined by documented SOPs, keeping devices controlled and separated as their handling requires. Storage conditions are part of the record.
Can procedure kits be assembled?
Yes. Procedure and component kits are assembled under SOP control with lot and UDI capture, so each kit is consistent and traceable to its inputs.
How does nearshoring affect duties on devices?
U.S. import duties apply when goods enter the United States. Under IMMEX, Mexican duties on imported inputs and components are deferred while goods remain in Mexico. Deferral applies to the Mexican side only.
What cost advantage does nearshore offer device brands?
Up to 30% lower handling cost versus a comparable U.S. facility, from lower labor and warehousing rates, without reducing control. Actual savings depend on volume, handling complexity and storage needs.
Does Lateral Fulfillment hold medical device certifications?
No. Lateral Fulfillment does not hold sector certifications and does not claim them. It provides capability-based handling — documented SOPs, lot-level and UDI traceability, and chain-of-custody records. The facility operates under IMMEX with CIVA and OEA.
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No minimum order volume. No long-term lock-in. If we're not the right fit, we'll say so on the first call.
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