One engineering team, one quality system, one floor, from a ten-piece first article to 260 million parts a year.
ISO 13485:2016 · BSI FM 590598/
FDA-Registered/
ISO Class 8 Cleanroom Environment Molding/
Made in the USA/
24/7 Operations
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. Suddenly a validated, shipping device 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:
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.
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.
Every serious molder shows you the same certificate. Ours reads it in the scope. A third-party auditor certified the words we live by.
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.
Your design, our manufacturability review. Technical sessions, DFM recommendations, feasibility on the parts others no-quote, & material selection support across every major LSR supplier.
Full tooling stewardship: requirements, mold design authority, cavitation strategy driven by volume and target price, mold-vendor selection and management, validation, and transfer.
Sampling and process development, FAI, MSA and DOE, IQ/OQ/PQ. Functional lot release defined.
Planned, staged scaling on one floor and one quality system: added cavitation and cells on a roadmap, 24/7 when the program demands it, and hundreds of millions of parts a year if the device earns it.
We take ownership of all of it, so you own none of it. Silicone or rubber, if your device needs a custom elastomer component, it comes off this floor.
One component discipline: custom silicone and rubber molding, secondary operations, and functional lot release, matched to whichever constraints lead in your application.
Qualify your molding partner once. Keep it for
the life of your device.
From clinical builds to commercial scale, engage our engineers at the print.
Start Your ProgramRevalidation is a given. We plan it around your inventory bank, so your line keeps running while we qualify.
Transfer Your Program