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.
ISO 13485:2016 · BSI FM 590598/
FDA-Registered/
ISO Class 8 Cleanroom Environment Molding/
Made in the USA/
24/7 Operations
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 Medical runs in one ISO Class 8 cleanroom environment, under the ISO 13485:2016 quality management system.
The four things your quality team will verify, and how each one works here. Certification is the given. This is what runs underneath it, lot after lot.
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.
New program or supplier transfer,
it starts with the print.
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