About IRP Medical/Since 1980

For device teams deciding who should mold the part the device cannot function without.

About IRP Medical

Since 1980, we have done one thing: mold the components medical devices cannot function without. Forty-five years is long enough to have carried programs from a first article to hundreds of millions of parts, and to know exactly what breaks in between.

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ISO 13485:2016 · BSI FM 590598/ FDA-Registered/ ISO Class 8 Cleanroom Environment Molding/ Made in the USA/ 24/7 Operations
Facility video · Oct 1-2 shoot
Why We Exist

The smallest part on the device
carries the biggest risk.

A valve that opens at the wrong pressure, or a seal that takes a set, can stop a program as surely as a failed circuit board. The part is a rounding error on the bill of materials and one hundred percent of the function.

The trigger

The supplier stops working

It fails an audit, gets acquired, exits the niche, or simply cannot scale with the program.

The scramble

The cost goes far beyond the part

Engineering teams chase root causes. Validation gets repeated. Qualifying a new molder becomes a project of its own.

The price

The launch or the line waits

Every week of requalification is a week the device is not shipping, for a part that costs cents.

Machine Mold Material Process

IRP Medical exists to take that risk off your team. We take ownership of the four things every quality part requires, then hold that process steady for the life of your device. Qualify once. Scale for the life of the device.

What Makes Us Different

Built for the whole life cycle.

Every serious molder has presses, engineers, and a certificate on the wall. The difference is what the company is built to serve.

Built for one end

The global silicone houses

Built for enormous automated programs. A two-hundred-thousand-piece Class II component is a rounding error to them.

Built for the whole curve

IRP Medical

One engineering team, one ISO 13485 quality system, and one press-based floor running everything from ten-piece first articles to high-volume automated cells. The supplier you qualify for your clinical build is the supplier you still have at full commercial volume.

Built for the other end

Generalist molders

Can take the small job, but cannot scale it or survive a medical audit.

Most device programs live in between: launching in the tens of thousands, heading toward commercial scale, and needing a partner that takes both ends seriously.

Highly rated on customer quality scorecards.

Our Commitments

What you can count on.

Engineering first

We start with what your part has to do, not just what is on the print. DFM, tolerance guidance, and material recommendations happen before a mold is cut.

Honest answers

We tell you what is realistic for your geometry and material, and how we will control it in production. If a part cannot be made right, we say so up front, before it costs you time.

One team from first article to production

The engineers who develop your part are the team that runs it. Nothing gets lost in a handoff.

Volume that fits your program

Including the medium and lower volumes larger suppliers often pass on, with a planned, staged path as your forecast grows.

Tooling management

We own the tooling process, from requirements and design through vendor management, validation, and transfer. You never deal with a toolmaker.

A process that stays locked

Once your part is validated, it is documented, controlled, and traceable under our ISO 13485:2016 quality system, so the part you approved is the part you keep receiving.

Somebody’s Important Customer

Big enough to scale.
Small enough to answer.

At a global supplier, a mid-volume program is one account among thousands. Here, it is a program the plant leadership knows by name.

Our operating partners bring more than twenty-five years each in the industry, and the people who run the floor join the customer calls. One U.S. site means one team, one quality system, and one place to audit. And when a program needs it, the floor runs 24/7.

Two IRP Medical engineers in cleanroom gowns reviewing a tablet beside a molding press
On the floor
It Takes a Team

The people you will
work with.

Precision molding is not just equipment. It takes engineers, technicians, quality specialists, and operations people who understand elastomers and medical devices: how a material behaves in a mold, how a process drifts, and how to catch a problem before it becomes a nonconformance.

Stefan Enjem

Vice President of Operational Excellence and General Manager

Stefan leads IRP Medical with a focus on operational excellence and continuous improvement, drawing on a career across aerospace, automotive, and food and beverage manufacturing.

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Hector Juarez

Business Development

Hector is the technical voice behind many of our customer programs, with deep experience in silicone molding and process development.

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Jon Barrett

Business Development

Jon brings a career spent in medical device manufacturing and helps device teams find the right path for new programs and supplier transfers, from first conversation through production.

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Ashley King

Key Account Manager

Ashley keeps active programs moving, from orders and scheduling to day-to-day customer communication, drawing on her background in the medical device industry.

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Tracy

Title to be confirmed
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Liquid silicone molding presses on the IRP Medical floor, with an operator inspecting a tray of parts
Cleanroom photo · Oct 1-2 shoot
Our Facility

One site.
One quality system.

IRP Medical operates from San Clemente, California. Our facility is ISO 13485:2016 certified and FDA registered, with molding in a certified ISO Class 8 cleanroom environment, and 24/7 operations when programs require it.

1035 Calle Amanecer, San Clemente, CA 92673
Our History

45+yearsof the same focus.

  1. 1980

    45+ years

    IRP starts in Rancho Dominguez, CA, with its first plant.

    Archive photo · pending

  2. 2015

    ISO 13485:2016

    ISO 13485 certification.

    Archive photo · pending

  3. 2022

    Milestone to be confirmed
    Archive photo · pending

  4. Today

    FDA registered

    San Clemente, CA.

    Facility photo · Oct 1-2 shoot
FAQ

Questions about
IRP Medical.

Where is IRP Medical located?
San Clemente, California, at 1035 Calle Amanecer.
Is IRP Medical a contract manufacturer?
No, not in the full-device sense. We mold custom critical-to-function silicone and rubber components, with overmolding, secondary operations, and sub-assembly capabilities. We make the components that go inside your device.
How long has IRP Medical been in business?
Since 1980.
What certifications does IRP Medical hold?
ISO 13485:2016, with a scope covering custom critical-to-function engineered components for the medical device industry, and FDA registration. The certificate is available on our Quality page.
Do you work with startups and smaller programs?
Yes, when there is a production program ahead. We support programs from first articles through high-volume production, including the medium and lower volumes that many larger suppliers avoid.
Can you take over a program from another supplier?
Yes. Supplier transfers are a core part of what we do, including tooling transfer, revalidation, and requalification. We plan the transfer with you so the timeline and the regulatory footing both hold.
How do I start a conversation with your team?
Start a program or transfer one from any page on the site. Send your print and an engineer responds. New programs typically begin under a mutual nondisclosure agreement.
Next Step

Let’s talk
about your part.

Whether you are starting a new device or moving an existing program, you will be talking to engineers from the first message.

Starting a new program?

From clinical builds to commercial scale, engage our engineers at the print.

Start Your Program

Transferring a program or mold?

Revalidation is a given. We plan it around your inventory bank, so your line keeps running while we qualify.

Transfer Your Program
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