Medical device manufacturers rely on cleanroom injection molding, documented quality systems, and validated processes to meet the requirements of regulated production. Detail Mold & Manufacturing holds the certifications, maintains the controlled environment, and provides the validation support those programs require, all within a single, vertically integrated facility. We manufacture under our customers’ FDA authorization, with our ISO 13485:2016 system governing quality on our end.
We build the tooling your medical injection molding program runs on, designed and documented to the same quality standards as the production it supports.
Plastic component production for medical device programs, with the process controls and documentation regulated supply chains require.
Cleanroom injection molding with ISO 13485 certification, in-house validation support, and real-time process monitoring for medical device manufacturers.
Precision machined components built to tight tolerances for medical device applications where dimensional consistency is non-negotiable.
For medical device injection molding companies, the credentials that matter most are the ones that govern how the work is done. Our quality management system and validation process are built around the standards your device can’t launch without.
Medical device components molded outside a controlled environment carry contamination risk your quality system has to catch before it reaches a patient. Our ISO Class 8 cleanroom holds particulate counts within that certified threshold from molding through assembly, and cleanroom assembly is available on-site, so your program stays inside a single controlled environment instead of shipping parts elsewhere to finish the job.
Our certifications cover the quality system, the cleanroom, and regulated programs under one roof, so your team qualifies a single supplier for mold build, molding, and validation.
Detail Mold & Manufacturing manufactures medical device components under our customers’ FDA authorization and within their documentation framework. Our ISO 13485:2016 certification governs the quality management system on our end, and our production documentation is structured to support our customers’ regulatory requirements.
Our IQ/OQ/PQ validation covers the full qualification sequence for medical injection molding programs. Installation Qualification documents that equipment is installed and configured to specification. Operational Qualification establishes the process boundaries, confirming the mold and press perform within required parameters. Production Qualification validates that the process consistently produces conforming parts.
Yes. We build injection molds and run production in the same facility. For medical programs, that means a mold built by our team can move directly into cleanroom injection molding production, with the same engineering team overseeing both phases. Customers with existing tooling can also bring it to our facility for cleanroom production without a new mold build.
Share your project details using the form below and our team will follow up directly. For questions about scope or capabilities, you can also reach us at 512.255.0525.
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