Contract manufacturing · Elbert, Colorado
Trusted medical device contract manufacturing partner since 1996 — non-automated manufacturing, assembly, and cleanroom packaging built around your specifications.
Our services
Every program runs through the same documented process: build, seal, label, verify — with your specifications and quality requirements driving each step.
Single-use and disposable medical devices, electro-surgical instruments, cardiac insulation pads, Class 1 devices, kit assembly and non-medical products — simple to complex builds.
Cleanroom packaging and sealing performed in our ISO Class 7 controlled environment, with pneumatic, heat, impulse and pouch sealing methods matched to your material set.
From simple information labels through to Microscan LVS barcode label verification, so every unit leaves with accurate, inspection-ready identification.
Why manual manufacturing
Automation rewards volume and punishes change. Our non-automated approach does the opposite: skilled hands, documented steps, and inspection at the point of assembly. That is what lets us take on complex builds, tight tolerances, and evolving specifications with over 100 years of combined industry experience behind the bench.
Simple or complex assembly, prototype through sustained production — all under an ISO 13485:2016 certified quality management system and an FDA registered facility.
Experienced technicians build and inspect at the bench, catching variation an automated line would pass straight through.
No tooling changeovers to justify. Low volumes, prototypes, and short-notice revisions are routine rather than exceptions.
In-process verification is built into the workflow under our ISO 13485:2016 certified quality management system.
From first-article builds through sustained production, the same team stays with your product — averaging 25+ years per client.
Inside our facility
Our Elbert, Colorado facility pairs an open production floor with a controlled environment cleanroom certified to ISO Standard 14644-1:2015.
Certifications & compliance
Past performance
Let's get in touch
Tell us about your device, assembly, or packaging program. We'll review your requirements and respond with a scoped quote — NDAs available on request.
