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ISO 13485:2016 · FDA Registered · San Clemente, CA
IRP Medical manufactures custom silicone and rubber components for medical devices under an ISO 13485:2016 quality management system, FDA registered, with ISO Class 8 cleanroom environment molding — in San Clemente, California. This page is the reference for your supplier qualification: certifications, cleanroom, and how parts are inspected, validated, documented, and traced.
The two claims a sourcing engineer checks first — stated plainly, with the certificate available for download.
IRP Medical is certified to ISO 13485:2016, the quality management standard for medical devices. The certificate scope reads "Custom Critical-To-Function Engineered Components" — the work itself, stated on the certificate.
IRP Medical's manufacturing facility in San Clemente, California is registered with the U.S. Food and Drug Administration. Registration details are available to customers as part of supplier qualification.
Contamination control isn't a finishing step — it's the environment the part is made in. Molding at IRP runs in an ISO Class 8 cleanroom environment, with quality assurance inside the room rather than down the hall.
The primary cleanroom houses the molding operations — liquid injection molding, gum molding, compression rubber molding, transfer molding, and overmolding / insert molding — with QA and testing stations inside it. The secondary cleanroom handles inspection, secondary operations, and device packaging.
| Space | Function | Floor Area |
|---|---|---|
| Primary cleanroom | Molding operations — liquid injection molding, gum molding, compression rubber molding, transfer molding, overmolding / insert molding — with QA and testing inside the room | [VERIFY] |
| Secondary cleanroom | Inspection, secondary operations, and device packaging | [VERIFY] |
The four things your quality team will verify — and how each one works here.
The QA lab sits inside the cleanroom. Automated non-contact vision metrology, custom inspection solutions engineered per program, and functional testing — inflation and leak — where the part demands it.
IQ/OQ/PQ process validation, supported by FAI, MSA, and DOE.
The quality management system is integrated with the ERP, and records are built as the work happens — audit-ready any day, not audit day.
Complete material and product traceability, lot by lot, from raw material receipt to shipped component.
Yes. IRP Medical is certified to ISO 13485:2016, the quality management standard for medical devices. The certificate scope reads "Custom Critical-To-Function Engineered Components" — the work itself, stated on the certificate. The certificate is available for download on this page.
Yes. IRP Medical's manufacturing facility in San Clemente, California is registered with the U.S. Food and Drug Administration. Registration details are available to customers as part of supplier qualification.
ISO Class 8. Molding at IRP runs in an ISO Class 8 cleanroom environment — a primary cleanroom for molding operations, with QA and testing inside the room, and a secondary cleanroom for inspection, secondary operations, and device packaging.
No — ISO 13485 is the quality management standard specific to medical devices, and it supersedes ISO 9001 for this work. A supplier certified to ISO 13485:2016 is held to the more demanding, medical-device-specific standard; a separate ISO 9001 certificate would add nothing to it.
Yes. The ISO 13485:2016 certificate is available for download on this page, and supporting quality documentation is available on request as part of supplier qualification.
New program or supplier transfer — it starts with the print. Send it, and an engineer responds.