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Medical Device Fulfillment and Healthcare 3PL Services With Serial-Level Records

KSP stores and ships finished medical devices and healthcare supplies for brands selling to patients, clinics and distributors. Serial numbers are scanned at dock receiving, at pack-out and on the outbound manifest, and the people handling your devices are background-screened and credit-checked. Prescription drugs, controlled substances, specimens and refrigerated products are out, and we tell you which of your SKUs we can handle before we quote.
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A KSP associate scanning inventory with an RF scanner
order accuracy across 32.1M orders
99.999%
shipping accuracy
99.95%
of CCTV footage kept on DVR
90days
issue response, on any issue
2hours

What Is Medical Device Fulfillment?

Medical device fulfillment is storing a manufacturer's or distributor's finished, labeled devices and supplies and shipping them to patients, clinics, hospitals and distributors. Every unit stays traceable by lot, expiry and serial number, so the brand knows which device went to which customer and when it shipped.

Two other jobs get described with the same words, and KSP does neither: pharmacy fulfillment, which dispenses prescriptions under a pharmacy license, and medical courier logistics, which moves specimens and urgent supplies between labs, hospitals and clinics.

We're a healthcare 3PL for finished goods: diagnostic and monitoring devices, OTC test kits, mobility aids, braces and supports, first aid and wound care, PPE, wearables and replacement parts, shipped as parcels to patients and as cases to clinics and distributors.

Fit Check: Devices and Supplies We Handle, and What We Turn Down

On the first call we ask for each SKU's device class, registration status and whether it needs refrigeration, a prescription or a hazmat shipping class. Those answers sort every SKU into one of the three groups below before we talk price.

ProductFitWhat decides it
Diagnostic and monitoring devices, wearables

We handle

Finished, labeled and stored at room temperature

OTC test kits, first aid, wound care, PPE

We handle

Lot and expiry recorded at receiving, earliest-dated stock ships first

Mobility and daily-living aids, braces and supports

We handle

Parcel and case sizes that ship without installation

Replacement parts and accessories

We handle

Serial captured on every SKU that carries one

Devices with built-in lithium cells

Review by SKU

In when the cells are installed and the unit ships as non-hazmat by ground

Sterile-barrier products

Review by SKU

Finished and sealed only, stored and shipped as received

Class II and Class III devices

Review by SKU

We check the records and handling your device needs against what we run

Prescription drugs, controlled substances

We don't handle

Pharmacy dispensing work

Specimens and lab samples

We don't handle

Courier work between sites

Refrigerated or frozen products

We don't handle

No refrigerated or frozen storage

Standalone batteries, power banks, aerosols, flammables

We don't handle

KSP doesn't take hazmat, dangerous-goods or limited-quantity products

Capital equipment that needs installation

We don't handle

White-glove delivery and install

Selling supplements or other dated wellness products next to your devices? They ship from the same building under the same lot and expiry records.

Device Class, Registration and Labeling: What Stays With You

KSP's FDA registration is a facility registration under the Federal Food, Drug, and Cosmetic Act, and our operations are ISO 9001:2015 compliant. Neither covers your device itself. Its classification, clearance and labeling stay with your company, and we keep the records that show where every unit went.

AreaKSPYour company
Registration

FDA facility registration under the Federal Food, Drug, and Cosmetic Act

Device establishment registration and listing

Classification and clearance

Uses your answers on the first call to decide which SKUs we handle

Device class, 510(k) or exemption status

Labels, UDI and IFU

Ships each device with the label and inserts it arrived with

Label content, UDI, IFU content and revisions

Lot, expiry and serial records

Recorded at receiving, tied to every order and pulled when you ask

Lot code and serial formats on your label

Complaints and adverse events

Order and serial history for any unit you're investigating

Complaint files and MDR reporting to FDA

Recalls and field actions

Holds the affected units and lists the orders that received them

The recall decision, FDA reporting and customer notice

Serial and Lot Records From Dock to Doorstep

Where each record is made

  1. Dock receiving

    Handheld RF scanners capture each serial, and the WMS checks it against your ASN and purchase order before put-away. A missing scan stops the receipt at the dock. Lot and expiry go in before the unit can be allocated to an order.

  2. Pick and pack-out

    The unit barcode is scanned at pick and again at pack-out, so the device in the carton matches the device on the order.

  3. Outbound manifest

    Serials are scanned onto the outbound manifest, linking each device to its shipping documents and tracking number.

  4. Earliest expiry ships first

    FEFO is the WMS default. Orders pull the earliest-dated lot, so short-dated supplies don't sit behind newer stock until they expire.

“We struggled with finding the right partner to put in place the best process for managing our business. Prior to implementing the KSP Program, we were riddled with non-conforming deliveries and customer complaints.” (Medical Packaging Org)

Who Touches Your Devices: Screened People, Controlled Storage

These controls decide who reaches your devices, from the people we hire to the cage your high-value stock sits in.

  • Background-Screened, Credit-Checked Staff

    Every employee is background-screened and credit-checked before they work on the floor.

  • Floor-to-Ceiling Security Cage

    High-value devices are stored in our floor-to-ceiling security cage. Their orders ship with signature required and declared value when you ask for it.

  • Monitored Around the Clock

    The building is professionally monitored 24 hours a day, 365 days a year, with electronic door access, motion detection alarms, secured dock doors and CCTV kept on a 90-day DVR.

  • Portal and an Account Manager on the Floor

    Inventory and order status show in your portal. Your dedicated account manager works on our floor and responds to any issue within 2 hours.

  • Supplier Audit Visits

    Before go-live, bring your quality team to our Brooklyn Park building and watch your units get received, scanned, picked and packed.

I'm loving your warehouse solution and wonder why I did not do this years ago. We really appreciate how smooth the transition was and how helpful everyone is with the onboarding. Thank you to all involved!

Medical Supply CoKSP client

Believe me when I say that I've seen a lot of warehouses. I would eat off the floor at KSP and put their customer service up against anyone. The process/flow, pride, discipline, and efficiencies had militaristic flavor. Top notch. We really look forward to building a huge business together!

Technology Healthcare RetailerKSP client

Patient Orders, Clinic Cases and Distributor POs From One Stock

Patients, practices and distributors each order differently, and all three draw from one inventory in our warehouse. A refill subscription and a clinic case never split your stock between two buildings.

  • Direct-to-Patient Parcels

    Single devices and refill supplies, packed to your packaging spec. Orders in by 2 PM CST ship the same day.

  • Clinic and Practice Orders

    Case quantities and mixed-SKU cartons for clinics, practices and hospitals, with each unit's lot and serial on the order.

  • Distributor and Retail POs

    Purchase orders arrive as EDI through SPS Commerce and ship as cases or pallets built to the buyer's routing guide. See how we run distributor POs over EDI.

  • Amazon, Shopify and Your Own Systems

    Any platform connects, through Logiwa or our custom API, and we build a new connection in as little as a week.

IFU Inserts, Starter Kits and Serialized Assembly

Starter kits, refill bundles and multi-part devices are built on our 50,000 sq ft kitting floor, where we've built 20.9 million kits. Here's how starter kit and refill bundle builds run for devices.

  1. Inserts counted with the components

    Your IFU, quick-start card and every component are lines on the bill of materials, counted at receiving, so we catch a short shipment of inserts at receiving.

  2. Built to the BOM

    Each kit is assembled to its bill of materials with your labels and inserts as you supply them. Any change to device labeling comes from your company.

  3. Component serials linked to the parent

    On multi-part devices, component serials are written to the finished parent SKU during assembly. When a kit comes back, you know which modules went into it.

  4. Checked before the box is sealed

    Every kit variant passes a BOM verification check before sealing, with photo QC at close.

Field Actions and Recalls at the Serial Level

A device recall can name a serial range instead of a whole lot. Every shipped unit carries its serial on the order record, so we scope a field action to the exact serials or lot you name and give you the orders, ship dates and ship-to addresses that received them.

  • The affected serials or lot go on hold in the WMS, and no new order can allocate them.
  • Units still on hand come out of pickable locations and are kept apart.
  • You get the order list and the on-hand count, then decide whether those units come back to you or get destroyed.

The recall decision, FDA reporting and customer notice stay with you. We stop the units moving and hand you the list.

Returned Devices: Quarantine, Match, Then Decide

Every return is checked before it goes near sellable stock, because the device that comes back isn't always the one that shipped.

  1. Held apart

    Returned devices go to quarantine, away from sellable stock, until they're inspected.

  2. Serial match

    The returned serial is checked against the unit that shipped on that order. A returned unit whose serial doesn't match one we shipped is refused, which settles swap and warranty disputes.

  3. Inspected and graded

    Seals and packaging are inspected, each return is graded, and you get a report of every return and its condition.

  4. Your disposition rule

    Sealed units go back to available stock, back to you for evaluation or to disposal, by the rule you set. Set opened single-use items to disposal and they never reach a shelf again.

What Sets the Price of a Device Program

We price a device program once we know which of your SKUs we handle, and walk you through an invoice and your program line by line. These five lines move the price most:

A KSP associate scanning a small carton with a handheld scanner
Serial-tracked SKUs

Each serialized unit is scanned at receiving, pack-out and manifest, so the share of your SKUs that carry a serial changes the labor.

Storage by lot

Each active lot of a SKU gets its own location, so many small lots take more space than a few large ones.

Kits and inserts

Starter kits, refill bundles and insert builds are quoted from the bill of materials.

Order mix

A patient parcel, a clinic case and a distributor pallet each take different picking and packing work.

Postage and counts

Parcels ship on our discounted carrier rates. Our scheduled cycle counts are included at no charge, because accurate inventory is our job.

What we'll talk through

  • Product categories and device class (I, II, III, not a device, or not sure)
  • Registration status for each device
  • Which SKUs carry a serial number
  • Any SKU that needs refrigeration, a prescription or a hazmat shipping class
  • Channels: patients, clinics, distributors, Amazon or web
  • Monthly orders

Medical Device Fulfillment FAQ

Do you fulfill prescription drugs or controlled substances?

No. KSP handles finished medical devices and healthcare supplies. Prescription drugs, controlled substances and pharmacy dispensing are outside what we do.

Can you store medical products that need refrigeration?

No. Our storage is climate-controlled and ambient, with no refrigerated or frozen space.

Does KSP's FDA registration cover medical devices?

KSP's FDA registration is a facility registration under the Federal Food, Drug, and Cosmetic Act. Device classification, registration and listing stay with your company as the manufacturer or distributor.

Do you record the serial number of every device you ship?

Yes, on every SKU that carries a serial. Serials are scanned at dock receiving, at pack-out and on the outbound manifest, so each order record holds the serial in its carton.

Can you match a returned device to the unit that shipped?

Yes. The returned serial is checked against the order it shipped on before any disposition.

What patient information do you need to ship direct to patients?

The ship-to name, address and order lines, the same as any parcel order from your store. Diagnosis, prescription and insurance details aren't needed to ship, so keep them out of the order feed.

Can you ship devices to clinics and distributors as well as patients?

Yes. Patient parcels, clinic cases and distributor POs over EDI all ship from the same stock.

Can our quality team audit KSP as a supplier before we ship devices?

Yes. Book a visit to our Brooklyn Park building and watch your units pass the serial scan points at receiving, pack-out and manifest. Every employee there is background-screened and credit-checked.

Can you ship lithium-battery devices?

Yes, when the cells are built into the device and it ships as non-hazmat by ground, which we confirm SKU by SKU. Standalone batteries, power banks and anything classed hazmat are out, because KSP doesn't take hazmat.

Get a Handling Plan and Quote for Every Device You Sell

Tell us what you sell. Our ops team will tell you which devices we handle and show you what fulfillment would cost.

  1. Answer five quick questions about what you ship and where you sell, with rough numbers.
  2. A KSP rep gets in touch within 1 business day to set up a short call and hear what you need.
  3. We build a fulfillment plan and a quote around your operation, then walk you through both line by line.

99.999% order accuracy across 32.1M orders.

No obligation, and nothing to send or prepare.

Not ready to talk yet? Get the Fulfillment Fee Checklist: the 14 lines a 3PL can bill you for, with the question to ask about each one.

Step 1 of 5

Who do you ship to?

Pick one or both.