One Partner.Every Operational Capability.
From FDA importation and contract manufacturing to warehousing, customer support, engineering, and field services, Preferred Depot brings the essential functions of U.S. operations together under one roof.
Our integrated teams, certified quality systems, and established infrastructure allow MedTech companies to launch faster, operate efficiently, and scale confidently, without building and managing each operational function independently.
Choose the services you need today. Expand seamlessly as your business grows.
Your First FDA Import, Handled End to End
The first shipment into the United States is the hardest one for a foreign device manufacturer. Your registration and device listing have to be in place, and a U.S. Agent, an Initial Importer of record and import documentation all have to line up before the product can enter. We handle the U.S. side of that, so initial importation becomes part of your U.S. operations instead of a one-off project.
U.S. Agent & Initial Importer
We represent you as U.S. Agent for FDA communications and act as your Initial Importer for devices purchased directly from your company, handling the complaint file and MDR reporting duties that come with it.
Import Documentation & Entry Review
Commercial invoice, packing list, FDA product code and entry paperwork prepared to match your registration. We answer FDA entry review questions during clearance so the shipment is not held at the port.
U.S. Labeling & UDI
Labeling built for the U.S. market, including UDI and GUDID support and re-labeling where needed, so your devices meet 21 CFR labeling requirements on arrival.
Receiving, Quarantine & Release
Your goods land in our FDA-registered Irvine facility, where they go through receiving inspection and quarantine release under 21 CFR Part 820 before any device reaches a customer.
Post-Import Compliance
From the first shipment onward: complaint handling, adverse event (MDR) reporting, lot-level traceability and recall readiness, all maintained for FDA inspection.
Registration, listing and clearance decisions rest with FDA and stay with your company. We handle the U.S. entry and post-import side, and we stay the accountable U.S. party for your devices after they clear.
Product-Lifecycle-as-a-Service
A subscription that covers the entire product lifecycle. Companies get a continuous operational engine, not just storage or shipping.
Operations as a science.
Engineering Support
Continuous technical expertise
ECO Updates
Engineering change orders managed
Firmware Updates
Remote update deployments
Field Failure Analysis
Root cause identification
Preventive Maintenance
Proactive issue detection
U.S. Compliance
SHIELD
U.S. Compliance Shield
A system that protects international MedTech companies from regulatory risks and compliance failures. Everything handled by PreferredDepot.
Reduces risk dramatically — something every international MedTech company struggles with.
Your U.S. COOA U.S. Executive Layer
We act as your COO and executive team — running your U.S. operations through PreferredDepot. You get top-tier operational command and senior leadership without adding headcount.
COO
Strategic operations leadership
VP Operations
Day-to-day execution
Engineering
Technical oversight
Compliance
Regulatory management
Supply Chain
Logistics optimization
Ready to change the way you think aboutU.S. operations?
The first fully integrated U.S. operational engine for MedTech. Something no one else is offering.