Medical Device fulfillment FAQ
What is medical device fulfillment?
Medical device fulfillment is storing, picking, packing and shipping medical devices and healthcare products under controls that preserve traceability and product integrity. In practice that means capturing lot, serial and expiry data, rotating stock by expiry date, segregating held or damaged units, storing product per its labeled conditions and keeping shipment records that support a recall.
Does a medical 3PL need to be FDA registered?
It depends on what the 3PL does. Under 21 CFR Part 807, establishments that relabel, repackage, import or manufacture devices must register with FDA, while a warehouse that only stores and distributes devices without changing them is generally not required to. We offer FDA-registered facilities in select markets for programs that involve activities like relabeling or kitting, and your regulatory team should confirm what your program requires.
Can you track lot and serial numbers for every shipment?
Yes. Lot, serial and expiry are captured at receiving from the device label, including GS1 UDI barcodes, and verified again at picking and packing. Each shipment record shows which lots and serials went to which consignee, on which date, in what quantity.
How do you support a medical device recall?
We support recalls by producing consignee-level distribution records for the affected lots or serials, placing remaining inventory on hold immediately and handling returned product in quarantine. The recall decision, FDA communication and customer notification remain the manufacturer's responsibility; our job is to make the data and the physical stock control fast and accurate.
Do you offer temperature-controlled storage for medical products?
Yes. Products are stored according to their labeled storage conditions, with monitored ambient and controlled-room-temperature storage available and 2–8°C refrigerated storage available in select markets. Excursions are logged and reported so your quality team can make the disposition decision.
Can you ship to hospitals and clinics?
Yes. B2B orders to hospitals, surgery centers, clinics and distributors ship with PO-matched packing lists, GS1-compliant carton labels and advance ship notices where required, by parcel or LTL. EDI connections for purchase orders, ASNs and invoices are available.
Do you handle DTC medical supply orders?
Yes. We ship direct-to-patient and direct-to-consumer orders for products such as home health supplies, mobility aids, wellness devices and over-the-counter diagnostics from Shopify and other storefronts, with discreet packaging available and the same lot tracking as B2B orders.
Do you sell or handle prescription drugs?
No. Our focus is medical devices and non-drug healthcare products. Prescription drug distribution falls under the Drug Supply Chain Security Act and state wholesale distributor licensing, which is a different program from device fulfillment. Some device programs also require state licenses, which we review during onboarding.
What happens to returned medical devices?
Returned devices are received into quarantine, never directly to sellable stock. Each return is inspected and documented, any reported malfunction is routed to your complaint-handling process, and the unit is restocked, scrapped or sent back only on your written disposition.
How is medical device fulfillment priced?
Medical device fulfillment is priced on storage, receiving, picking and packing, plus any value-added work such as kitting, temperature-controlled storage or EDI. We do not publish rate cards because controls differ by product; you get a transparent, itemized custom quote within one business day.