Medical device contract manufacturers registered with the FDA

Nobody publishes the price. Read what they do publish.

Ask a US medical device contract manufacturer what a pilot build costs and the website will not tell you. Of the 19 firms we read in September 2026, including Jabil, Integer, Flex, Sanmina, Plexus, Viant, Cirtec, Nordson, TekniPlex, Kimball, Medical Murray, Nortech, Cadence and Pathway MedTech, none publishes an NRE fee, a unit price, a minimum order for a custom device, or a production lead time. Viant's own FAQ asks "How much does medical device assembly and packaging cost?" and the answer on the page gives no figure.

The only published minimums and prices in the whole group belong to catalog parts, not contract builds. Nordson's fluid components are sold in 100 piece minimums and multiples of 100, with a $100 order minimum on phone orders, and parts not in stock usually ship in 2 to 4 weeks. DuPont Spectrum's webstore sells standard medical tubing in 5 piece lots, for example single lumen Pebax tubing at $149. Useful if you need tubing for a prototype this week. Irrelevant to what your device will cost to build.

So the comparison has to be built from other facts, and the useful ones are published. Device class tells you who has built something with your risk profile. Cleanroom class tells you whether they can assemble a sterile product. The startup stance tells you whether your 200 unit clinical build will get attention. And the terms of sale tell you what you are agreeing to before anyone quotes a number. The table below puts those side by side.

The tooling you pay for may not be yours

This is the finding that should change how you read a quote. Two large contract manufacturers publish terms of sale that give them the tooling. TekniPlex's US sales terms say any mold or tooling "regardless of which party has paid for it, shall be Seller Property." Viant's quotation terms say tooling made by the seller "is proprietary to Seller." The same TekniPlex terms let the seller ship up to 10% over or under the quantity ordered, and Viant's quote terms state net 30 payment and a $150 minimum restocking charge.

None of this is unusual or sinister. A molder that builds and maintains a tool often wants to keep it, and Nordson states the opposite trade openly: for custom fluid components it supports the tooling for the life of the product, covering maintenance, repairs and capacity expansion, as long as supply contracts are in place. But for a device startup the consequence is concrete. If the tool belongs to the manufacturer, moving production to a second source means paying for a new tool and repeating the process validation on it, which is months, not weeks.

Kimball states the other half of the ownership question in writing: customers own the intellectual property after design acceptance. Ask for both in your first conversation. Who owns the design outputs, and who owns the steel. Then write the answer into the supply agreement before you approve a tooling invoice, because the terms on the back of the quote will govern if you do not.

Who takes a startup's first build, in writing

Most firms will say they work with companies of all sizes. Only some put a startup or low volume stance on the page, and those are the ones worth briefing first for a pilot or clinical build.

Nortech Systems in Maple Grove, Minnesota goes furthest: startups without a formal or experienced quality system can rely on Nortech's ISO 13485 certified product development quality system as their own, and its Mankato and Bemidji sites are set up for low volume, high mix products. Medical Murray in the Chicago suburbs states it serves customers from startups to the largest OEMs and runs low volume pilot production for clinical trials, including single lot orders. Viant answers the question directly: yes, it partners with early stage startups and supports low volume prototype runs through high volume production. Pathway MedTech in Santee, California says it is built for low to mid volume new product introduction and names the buyer it is for: production volumes too small for traditional contract manufacturers.

Others state a range instead of a stance. Forj Medical (formerly Minnetronix) says from 10 units to 10 million. HDA Technology in Lake Forest, California says ten units or ten thousand. Cadence says a few hundred units or millions annually. Cirtec lists emerging startups alongside established OEMs, with prototyping and low to mid volume production at Santa Clara. The large EMS names (Jabil, Flex, Sanmina, Plexus) publish no startup program at all, which does not mean they will refuse you, only that a 500 unit build is not what their pages are written for.

A US headquarters is not a US plant

Nearly every large medical contract manufacturer has a US headquarters and plants outside the US. That is normal, and it matters for three reasons: a made in USA claim, import duty on the finished device, and where your quality team flies for the audit.

From their own location pages: Integer is headquartered in Plano, Texas, with plants in Minnesota, Florida, Pennsylvania and New York, and also in Juarez, Tijuana, Santo Domingo, Montevideo, Ireland and Penang. Viant is based in Foxborough, Massachusetts, with 26 locations including Tijuana, Heredia in Costa Rica, Suzhou and three European sites. TekniPlex's contract manufacturing comes largely from Seisa Medical in El Paso, with plants in Ciudad Juarez and Slovakia. Nortech builds in Minnesota, Monterrey and Suzhou, and notes its China and Mexico sites take production once volumes reach a higher threshold. Cadence runs finished device assembly in Cranberry Township, Pennsylvania and Alajuela, Costa Rica.

If US production is a requirement, say so in the brief and ask which site the quote is for. Medical Murray (two Illinois sites), Pathway MedTech (Santee, California) and HDA Technology (Lake Forest, California) publish US only footprints. A device finished in Tijuana or Costa Rica and shipped into the US also needs a tariff classification and a landed cost, which is a customs question we do not answer, so involve your broker early.

The name on last year's list may not be the company you sign with

Medical contract manufacturing consolidates constantly, and the lists that rank for this search are full of names that have changed. Reading the vendors' own sites in September 2026: Minnetronix Medical now operates as Forj Medical. SteriPack now trades as Ensera. Providien's device assembly, machining and molding business now sits under Amphenol CMT, with its thermoforming business separate. Donatelle Plastics became part of DuPont in July 2024 and is now part of DuPont Spectrum. Nordson completed the sale of select product lines in its medical contract manufacturing business to Quasar Medical on September 2, 2025. TekniPlex bought Seisa Medical in December 2023. Kimball Electronics is rebranding as Kimball Solutions from July 1, 2026.

For a device company this is not trivia. Your quality agreement, your supplier audit and your registration records name a legal entity. After an acquisition the site may be the same while the quality system, the certificate holder and the terms of sale change. Before you sign, confirm the legal entity on the ISO 13485 certificate, the FDA registration for that specific site, and which terms of sale now apply.

What "FDA registered" means, and what it does not

FDA registered is the phrase buyers search for most and misread most often. Under 21 CFR 807, both the contract manufacturer (including contract packagers) and the specification developer, the company whose design it is, must register their establishments and list their devices with the FDA each year and pay the annual fee. That fee is $11,423 for fiscal year 2026 and rises to $13,785 for fiscal year 2027, which starts October 1, 2026.

Registration is a notification, not a qualification. The regulation is blunt: "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products." A representation that creates an impression of official approval because of registration is treated as misbranding. So "FDA registered contract manufacturer" is a floor. What you actually want is behind it: whether the registration is current for the specific site that will build your product, what its inspection history looks like, and whether its quality system can carry your design transfer.

The registration also tells you something about your own obligations. Because the specification developer registers too, you do not hand the regulatory burden to your contract manufacturer. Your marketing submission, your device listing, complaint handling and supplier controls stay with you.

Where a contract manufacturer sits in your quality system

Outsourcing the build does not outsource the responsibility. Since February 2, 2026 the FDA's Quality Management System Regulation has incorporated ISO 13485:2016 by reference into 21 CFR Part 820, so the supplier controls your contract manufacturer lives under are the same ones in the standard your certificate holder is audited to. Your contract manufacturer is a supplier inside your quality system, and establishing and auditing that control is your job.

The document that makes it work is the quality agreement, and this is another place where websites go quiet. Of the 19 firms we read, only Integer mentions quality agreements at all, describing them as a way to clarify roles and responsibilities. Cirtec says its quality system can support or integrate with your own. Nobody publishes a template. Expect to write, or at least negotiate, the agreement yourself: who owns change control, which changes require your approval before they are made, what device history records you receive, how nonconformances and CAPA are communicated, and who handles complaints.

A contract manufacturer used to operating inside a customer's quality system will answer those fluently in the first call. One that treats them as paperwork is a risk you will absorb later, usually during your own FDA inspection rather than theirs.

What to send a medical device contract manufacturer

Because nobody publishes a price, the quality of the proposals you get back depends almost entirely on the brief you send. A brief that works includes: the device description and intended use; the device class and regulatory path (exempt, 510(k), De Novo, PMA); the design status (prototype, design frozen, verification complete); the processes involved; the pilot, clinical and first year production quantities; sterile or non sterile, and the sterilization method if known; the cleanroom class needed; where it must be built; and the date you need validated units.

Then ask the same five questions of every firm. What is the NRE for design transfer and validation, separate from the unit price. Who owns the tooling and design outputs. Which site builds it and what is that site's registration. What the proposal assumes for annual volume, because Viant's quote terms state plainly that prices are based on assumptions about annual demand, minimum order quantities and tooling. And when the lead time starts counting: from purchase order, from design freeze, or from completed process validation. The answers to that last question are rarely on a website, and they decide whether your launch date is real.

If you would rather not build that list by hand, our RFQ tool sends one brief to every shortlisted manufacturer and lines the answers up, and our comparison of medical device contract manufacturing companies goes firm by firm on who to brief first.