We deliver ISO 13485-certified medical device manufacturing services in a cleanroom environment. With 20 molding machines—including injection molding and injection blow molding units—we support clean, compliant plastic injection molding manufacturing from pilot to scale.
Let’s TalkOur medical device manufacturing services combine Class 8 cleanroom control, RNase/DNase-free production, and injection molding capacity to meet your volume, compliance, and quality needs. From precision prototypes to full-scale programs, we deliver reliable results at every step.
We manufacture, assemble, and package medical and diagnostic parts in our cleanroom, protecting product integrity, traceability, and safety.
With 16 injection and 4 injection blow molding machines on-site, we support plastic injection molding manufacturing at scale.
We move fast and invest in what matters—offering customized production plans that align with your timelines, volumes, and goals.
All molding, assembly, and packaging follow strict gowning and gloving procedures. We support sterile and RNase/DNase-free medical component manufacturing for PCR test kits and other sensitive diagnostics.
Our medical device manufacturing services are rooted in collaboration. We work side by side with OEMs to solve challenges, adapt to evolving needs, and scale production together. As a privately owned partner, we stay flexible, responsive, and invested—building long-term relationships that extend well beyond the first production run.
Our process starts in an ISO Class 8 cleanroom, with dedicated setups for plastic injection molding manufacturing, ensuring compliant production from the first shot.
We support cleanroom-compatible assembly and handling during molding or post-process, protecting product integrity through gluing, welding, or manual assembly.
Our medical component manufacturing is documented for traceability—tracking batches, materials, and tooling data to meet ISO 13485, FDA, and customer audit expectations.
We support validation and scale-up with IQ/OQ/PQ protocols, quality controls, and flexible capacity—setting your product up for consistent long-term production.
We offer injection molding and injection blow molding—optimized for precision, compliance, and scale in cleanroom environments.
We operate an 8,000 sq. ft. ISO Class 8 cleanroom with injection molding and injection blow molding, built for high-quality, compliant component production.
From manual to automated assembly in our white room and cleanroom, we deliver finished components with precision, speed, and traceability.
We’re more than a supplier—we’re a strategic partner. As a family-owned company, we move fast, stay flexible, and invest in what matters.
Our collaborative mindset and technical depth help OEMs turn great ideas into manufacturable solutions.
Learn More About UsWe help OEMs bring complex molded components to life—with the care, speed, and flexibility they depend on.
Every part we produce follows ISO 13485-certified processes and plastic injection molding manufacturing standards. We maintain traceability, RNase/DNase-free protocols, and cleanroom best practices, ensuring consistent quality for regulated medical components.
Yes. Our medical device manufacturing services support pilot runs and commercial volumes alike. With 16 injection and 4 blow molding machines, we meet your scale, speed, and compliance needs—without compromising precision.
