Is Jay Group an FDA-registered 3PL for medical devices?

Yes. Applicable Jay Group facilities are FDA-registered, and we’re also DEA-registered and ISO/IEC 27001 certified — so your product handling, your controlled products, and your data all meet the standards regulated device brands require, with full lot, serial, and UDI traceability.

Is Jay Group tech-driven?

Yes. We built our own proprietary order management system — real-time visibility, AI-powered forecasting, and deep reporting through a client access portal — and run it on Manhattan Associates WMS, a longtime Leader in the Gartner Magic Quadrant for Warehouse Management Systems — the combination behind your unit-level serial and lot visibility.

How does Jay Group handle expiration dates, sterility, and recalls?

We capture lot, batch, and multi-level serial numbers within your UDI framework and support FIFO, LIFO, FEFO, and stop-ship date management. For dated and sterile stock we pick FEFO so the units closest to their date ship first — so in a recall we can isolate affected inventory quickly, quarantine it, and document exactly which orders it shipped in.

Does Jay Group handle medical device returns?

Yes — reverse logistics is a strength. Returns are inspected and dispositioned by lot, serial, and expiration date, in-date sellable units go back to stock, anything requiring a quality hold is quarantined and documented, and results sync to your systems in real time.

Can Jay Group support e-commerce, subscription, and wholesale at once?

Yes — that’s what omnichannel means here. DTC across Shopify, Amazon, and TikTok Shop, subscription and continuity programs, and B2B wholesale with full SPS Commerce EDI integration, all from one inventory pool.

What makes Jay Group different from tech-forward 3PLs?

Most brands are told to choose between a tech-forward platform and a hands-on operator. Jay Group is both: a proprietary, AI-powered platform on an enterprise WMS, running in warehouses we own and operate ourselves, with a team that stays for years and compliance few 3PLs can match — FDA-registered, DEA-registered, ISO 27001, with full UDI, lot, and serial traceability. And because we’re family-owned, you’re a client, not a line in an investor’s return.

Who is the best fit for Jay Group?

Jay Group is built for emerging, fast-growing medical device and healthcare brands scaling their fulfillment — generally those shipping at least 5,000 orders a month. We’ll consider brands below that on a case-by-case basis, but 5,000-plus per month is our sweet spot.

3PL Fulfillment for Medical Device Brands

Jay Group is an omnichannel 3PL: we run direct-to-consumer e-commerce, recurring subscription and continuity programs, and B2B wholesale from a single controlled pool of inventory, so a medical device brand can sell everywhere without fragmenting its stock. Most device brands aren’t on one channel — they’re shipping consumer rush orders off Shopify, listing on Amazon, running a reorder program for consumables, and sending bulk replenishment to clinics and distributors, all at once — and the moment each pulls from separate inventory, you get oversells, expired stock, and shipments that can’t be traced to a lot. One operation and one accurate inventory position keeps a scaling brand out of that trap.

And here’s the part worth saying first: we don’t broker your product to a network of warehouses we don’t control. We own and operate our facilities directly. For a regulated, serial-tracked, recall-sensitive product like a medical device, who actually stands on the floor is not a detail — it’s the whole question. Ask any 3PL two things: do you operate the building my product sits in, or broker it, and who do you ultimately answer to.

Advanced Kitting, Bundling & Branded Packaging

Medical device brands rarely ship a single unit. You ship procedure kits, starter kits, device-plus-consumable bundles, replacement-part packs, clinician sample kits, subscription refill boxes, and retail-ready and shelf-ready displays — each an assembly job, not just a pick. This is a core strength. We run contract packaging and kitting and assembly under one roof, with quality-critical inspections and package integrity testing where a build needs them, so complex multi-SKU orders get assembled accurately instead of by hand. Point-of-sale and point-of-purchase displays, shelf-ready packaging, insert and IFU (instructions-for-use) management, and branded packaging all run with the same compliance-controlled team.

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3PL for Shopify Fulfillment

Shopify is where most device brands run their owned store, and it’s where we start. Our integration syncs orders, inventory, and tracking between Shopify and our warehouse in real time, so your storefront always shows accurate available-to-sell and you never oversell a unit you don’t have. Orders drop to the floor automatically, tracking pushes back to the customer untouched, and the subscription and continuity apps device brands rely on for consumables map cleanly into how we pick and ship. Consumer rush orders go out same-day; bulk replenishment to a clinic gets built to that account’s spec. As you scale into the thousands of orders a month, the operation scales with you.

3PL for Amazon Fulfillment

FBA, FBM & SFP

Amazon is unforgiving for regulated goods. Expiration dating, serial capture, prep, poly-bagging, and labeling all have to be exactly right, or shipments get held and your listings go dark. We prep FBA shipments to Amazon’s exact spec — including the expiration-dated, lot-controlled, and serialized requirements specific to devices — so inventory checks in clean the first time. For brands that would rather hold stock with us, we run FBM and Seller-Fulfilled Prime, so you keep the Prime badge while controlling your own inventory, keeping full lot and serial visibility, and sidestepping long-term storage fees.

3PL for TikTok Shop Fulfillment

TikTok Shop has become a real channel for consumer health devices — wearables, monitors, wellness and recovery tech, at-home diagnostics — and it rewards speed while punishing late fulfillment. A single video can 10x your order volume overnight, and the platform’s ship-window SLAs don’t flex; miss them and you get penalized right as you’re going viral. We’re built to absorb that spike and ship inside the window, turning a breakout moment into revenue instead of cancellations and account strikes — while still capturing the serial and lot data a device requires.

3PL for Walmart & Target Fulfillment

Selling into the big-box marketplaces and enterprise stacks is its own discipline. Walmart, Target, and NetSuite all connect through our integrations over the API, so orders and inventory move in real time and your team keeps living in the system it already uses. Whether it’s marketplace or first-party retail, the data stays accurate underneath — and the wholesale and retail compliance side runs through SPS Commerce, covered next.

Wholesale fulfillment & SPS Commerce integration

When a device brand wins its first real distributor, health-system, or big-box account, fulfillment stops being about parcels and becomes about compliance. Retailers run strict routing guides, and one missed label, wrong pallet, or blown ship window becomes a chargeback that quietly eats your margin.

This is where SPS Commerce matters, and it’s specifically a wholesale capability. Jay Group is fully integrated with SPS Commerce for EDI, so your purchase orders flow in electronically, your advance ship notices and invoices flow back automatically, and every order is built to each account’s exact spec. Routing-guide compliance, retail and case labeling, pallet and case configuration, ASN and documentation — the unglamorous work that keeps chargebacks off your invoice — is handled by a team that has run wholesale fulfillment for decades. For a brand moving into national retail, distributor, or GPO channels, that discipline decides whether a wholesale account makes money or loses it.

FDA-registered medical device fulfillment

Medical devices are regulated, and your 3PL is part of your regulatory footprint whether it behaves like it or not. Every applicable Jay Group facility is FDA-registered — the credential that matters most for a device brand, because it means the warehouse holding your product is held to the standards regulators already expect of you, and it makes documented quarantine procedures, controlled holds, and recall tracking real rather than aspirational. We’re also ISO/IEC 27001 certified for information security, DEA-registered, and temperature- and humidity-controlled, so your data is protected, controlled substances and combination products most providers can’t legally touch are handled properly, and moisture-sensitive electronics and sterile goods are shielded from the conditions that degrade them. Behind it all sits documented quality management, sanitary handling, pest-free warehouses, and handlers trained specifically for medical product. FDA registration is the headline; the rest is the depth behind it.

Lot, batch & serial tracking

For a device brand, traceability isn’t a feature — it’s insurance against the worst day your company will have, and often a legal requirement. Jay Group tracks lot and batch numbers, captures multi-level serial numbers, and works within your Unique Device Identification (UDI) framework, down to the unit and case level on Manhattan Associates warehouse management technology. Every device that ships is tied to its lot and its serial, which lets you answer a hospital’s, a distributor’s, or a regulator’s traceability question with a document instead of a guess. Recall management is where this earns its keep: if a component issue, a supplier problem, or a quality hold surfaces, we can isolate the exact affected inventory in hours and prove which orders it did and didn’t ship in — the difference between a controlled, narrow recall and a company-ending scramble.

Hazmat handling & compliant storage & shipping

A growing share of devices ship with lithium batteries or other regulated materials, which turns an ordinary order into a hazmat shipment with real rules behind it. Jay Group handles hazardous materials to 49 CFR, IATA, and IMDG standards, including Classes 2, 3, and 9 and the lithium-battery expertise most consumer and wearable devices now require, and our system flags hazmat orders automatically so the right packaging, marking, labeling, and documentation get applied every time. For fragile, high-value electronics we also handle blocking and bracing and moisture protection, so a device arrives intact and compliant.

Returns management & reverse logistics

Returns are where a lot of device margin quietly disappears — and where Jay Group is genuinely strong. Regulated, serialized, date-sensitive products are expensive to get back and re-handle: a return that arrives near or past its date, or with broken sterility, can’t simply go back on the shelf. We run reverse logistics as a real operation. Inbound returns are inspected and dispositioned by lot, serial, and expiration date; in-date, sellable units go back to stock; and anything that can’t be resold — or has to be quarantined for a quality review — is documented and handled cleanly against the same records, with the outcome synced to your systems in real time.

The medical device Categories We Handle

Not every 3PL is set up for the full range of device and healthcare SKUs. Jay Group handles medical devices, durable medical equipment (DME), diagnostic instruments and at-home test kits, surgical devices, dental supplies, wound care, orthopedic braces and supports, hearing aids and wearable and battery-powered devices, skin care products, and dietary aids and adjacent health and wellness lines. High-value inventory gets secured storage and closely monitored handling, and everything runs under the same FDA-registered compliance and lot, serial, and UDI traceability standards — so a brand can add product lines without outgrowing its partner.