Choosing a 3PL for Medical Devices: What to Verify
How to evaluate a third-party logistics provider for medical device distribution, from FDA registration and lot control to system integration and recall readiness.
A 3PL that ships consumer electronics well may still be a poor fit for medical devices. The difference is not care in handling; it is records. Device distribution requires lot-level traceability, documented procedures, temperature control where applicable, and a recall process that can identify affected inventory and customers quickly. Those are auditable capabilities, and they can be verified before contract.
Why general logistics capability is not enough
Consumer fulfillment optimizes speed per order. Device fulfillment optimizes the integrity of the record per unit. A warehouse that cannot tell you which lot shipped to which customer, with a timestamp and a picker, cannot support a recall or a complaint investigation, regardless of how clean the floor looks.
Questions that reveal a real medtech 3PL
- Are the facilities FDA registered as medical device establishments, and what is the registration number?
- Which quality system governs the operation, and when was the last internal or external audit?
- How are lots, serial numbers and expiration dates captured at receipt, put-away, pick and ship?
- What temperature-controlled capacity exists, and is monitoring validated and alarmed?
- Can you produce a full distribution history for a specific lot within one business day?
- How are quarantined, expired and damaged units isolated and dispositioned?
- What does a mock recall look like, and will you run one with us before go-live?
Cost structures and what they hide
Per-pallet storage plus per-order fulfillment is the standard model, and it is reasonable. The items that change total cost are exceptions: inbound discrepancies, kitting, relabeling, returns disposition, special handling and reporting requests. Ask for the exception rate card, not just the headline rates, and ask how exceptions are documented.
Transitioning without a stockout
A transition works when inventory is counted at both ends, the cutover date is fixed, open orders are frozen or dual-run deliberately, and the new site validates receiving against your records. Running a small pilot shipment through the new process before moving the full book is the cheapest insurance available.
Need this applied to your device?
We run U.S. entry, warehousing, fulfillment and post-market support for medical device manufacturers. Bring the specifics and we will map the steps.