IRP MEDICAL
Custom Medical-Grade Silicone & Elastomer Molding · San Clemente, California · Since 1980

Critical-to-function silicone components, molded for the whole life of your device.

One engineering team, one quality system, one floor — from a ten-piece first article to 260 million parts a year.

Start Your Program → Transfer Your Program →
Send your print → — an engineer responds.
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Hero Image / Video
Real-floor production photography — cleanroom LIM cell in motion, CTF component macro, or QA inside the cleanroom.
ISO 13485:2016 · BSI FM 590598 FDA-Registered ISO Class 8 Cleanroom Environment Molding Made in the USA 24/7 Operations
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Line-down / audit pressure moment
The Problem

The most expensive supplier decision is the one you have to make twice.

The shop that carried your clinical builds caps out at commercial volume. The global house never took those builds seriously. Or the incumbent fails an audit, gets acquired, or exits the niche — and a validated, shipping device suddenly needs a new supplier, a new qualification, and a story for regulatory.

There's a name for it: the mid-life re-source. Its costs are invisible the day the supplier is chosen, and they all arrive mid-life:

Revalidation Spend Launch Slip Line-Down Exposure The Post-Mortem
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QA inside the cleanroom
The IRP Solution

Qualify once, and keep the same supplier for the life of the device.

One engineering team, one quality system, one floor — carrying the program from a ten-piece first article through full commercial volume. The volume threshold that forces a re-source somewhere else is just a capacity conversation here.

~100% On-Time Delivery Passed Customer Supplier Audits QA Lab Inside the Cleanroom 24/7 When the Program Demands It
Why IRP Medical

We know the squeeze.

Too small for the global silicone houses to notice. Too critical to hand to a job shop. That's where most medical device programs actually live — and it's exactly what IRP Medical is built for.

Since 1980 we've molded the custom medical components devices can't function without — and not just the one part you buy from us today. Long enough to have carried programs from a first article to their two-hundred-millionth part, and to know what breaks in between.

ISO 13485:2016 Scope — Verbatim
"Custom Critical-To-Function Engineered Components"

Every serious molder shows you the same certificate. Ours reads it in the scope, verbatim — a third-party auditor certified the words we live by.

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The floor, wide (primary)
CTF component macro
Cleanroom LIM press cell
Materials & compounds
How It Works

The Precision Path — first article to full scale, without the re-source.

You shouldn't have to guess how a molding program will go. Here's the path, in four stages — the same four whether the run is ten pieces or a hundred-million-part year.

Engineers over a print / DFM session
1

CTF Design Integration

Your design, our manufacturability review. Technical sessions, DFM recommendations, feasibility on the parts others no-quote, and material selection support across every major LSR supplier.

What it means: you're not alone with the hard part.
Mold build / cavitation detail
2

Validation-First Tooling

Full tooling stewardship: requirements, mold design authority, cavitation strategy driven by volume and target price, mold-vendor selection and management, validation, and transfer.

What it means: you never manage a toolmaker, and the volume cliff never gets cut into steel.
Metrology / functional test station
3

Process Lock

Sampling and process development, FAI, MSA and DOE, IQ/OQ/PQ. Functional lot release defined.

What it means: you qualify once, on evidence.
Automated cells running at rate
4

Scaled Production

Planned, staged scaling on one floor and one quality system — added cavitation and cells on a roadmap, 24/7 when the program demands it, to hundreds of millions of parts a year if the device earns it.

What it means: you never outgrow us.
Capabilities

Every quality part requires four things: a machine, a mold, a material, and a process.

We take ownership of all four — so you own none of them. Silicone or rubber, if your device needs a custom elastomer component, it comes off this floor.

Cleanroom LIM press cell

Machine

Late-model LIM presses, fully automated work cells, robot demolding, in-mold vision systems, cleanroom environment molding, 24/7 operations.

Learn More →
Tooling / cavitation

Mold

Full tooling stewardship: mold design, DFM, cavitation strategy, vendor management, validation, transfer.

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LSR & rubber compounds

Material

LSR from every major supplier, HCR gum silicone, EPDM, fluorosilicone, conductive grades, organic and synthetic rubber compounds, custom formulation to spec.

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Process monitoring

Process

Scientific molding techniques. Validated (IQ/OQ/PQ), lean, flashless where it matters.

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Molding floor: LIM, compression, overmold

Molding & Materials

Liquid injection molding (LSR/LIM), HCR gum silicone injection, compression rubber molding, transfer, and flashless molding. Overmolding / insert molding onto metals, and silicone overmolding onto silicone and thermoplastic substrates including PC and ABS. Silicone extrusion — tubing and rod, cut to size.

Learn More →
Engineering review: print, CAD, part

Engineering & Manufacturing

DFM and product realization, tooling stewardship, FAI/MSA/DOE and IQ/OQ/PQ validation, cleanroom environment molding, non-contact vision metrology, lean NPI.

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Slitting, finishing, packaging

Secondary Operations

Precision slitting, die cutting, laser marking, cryogenic deflashing, alcohol washing, duckbill and valve finishing, sub-assembly, and packaging.

Learn More →

Every step we absorb — through sub-assembly and packaging — is one your team doesn't have to source, qualify, and manage.

Applications

The components behind the devices people depend on.

One component discipline — custom silicone and rubber molding, secondary operations, and functional lot release — matched to whichever constraints lead in your application.

Infusion set components

Diabetes

Our largest market — infusion set and pump components at sustained, automated volume.

Explore Diabetes →
On-body device components

Wearables

Skin-contact silicone and bonded sub-assemblies that flex with the wearer and scale when the product wins.

Explore Wearables →
Valves, septa, tubing

Fluid Path

Check valves, duckbill valves, septa, seals, and silicone tubing — released on function.

Explore Fluid Path →
Skin-contact components

Women's Health

Soft-durometer, skin-contact silicone with materials selected to the biocompatibility spec.

Explore Women's Health →
Cardiovascular components

Cardiology

Critical components for programs where qualification is measured in years.

Explore Cardiology →
Diagnostic consumables

Diagnostics

Gaskets, seals, valves, and fluid-handling parts where repeatability decides whether the assay runs.

Explore Diagnostics →
Surgical instrument parts

Surgery

Seals, diaphragms, and bonded sub-assemblies that hold their response through repeated sterilization cycles.

Explore Surgery →
Wound-care silicone

Wound Care

Gentle, biocompatible silicone repeatable enough to trust for wear measured in days.

Explore Wound Care →
Closures & septa

Pharma

Septa, seals, and closures where compound selection and contamination control carry the regulatory weight.

Explore Pharma →

Tell us your application.

These are the applications we're in most often — not the limit. If the part is a custom, critical-to-function elastomer component, we can almost certainly mold it. Send the print and we'll tell you fast.

Tell Us Your Application →
Qualify Once

When medical components have to perform.

Qualify your molding partner once. Keep it for the life of your device.

Starting a new program?

From feasibility and clinical builds to commercial scale — engage our engineers at the print.

Start Your Program →
Send your print — an engineer responds.

Transferring a program or mold?

Moving a validated component means revalidation — that's a given. We plan it around your inventory bank, so your line keeps running while we qualify.

Transfer Your Program →
Send your print — an engineer responds.
IRP Medical molds critical-to-function silicone and elastomer components for medical devices — from ten-piece first articles to hundreds of millions of parts a year, on one ISO 13485 floor. Qualify once. Scale for the life of your device.
1035 Calle Amanecer, San Clemente, CA 92673
Main (949) 373-4513 · Customer Service (949) 373-4511

Capabilities

Molding & MaterialsEngineering & ManufacturingSecondary Operations

Programs

Start Your ProgramTransfer Your ProgramCTF Molder Audit ChecklistSupplier Transfer Playbook

Company

AboutQualityApplicationsContact
ISO 13485:2016 · BSI FM 590598 FDA-Registered Since 1980
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