The Boulder BioMed Family
One campus, one quality system. Together, the Boulder BioMed companies provide everything a medical device needs to reach market — and the reason our regulatory and quality advice is grounded in operations is that these operations are our own.
We design & manufacture
Boulder iQ
Engineering, design, development, and manufacturing. An FDA-registered establishment that builds devices under design controls.
We sterilize
Boulder Sterilization
Ethylene oxide and chlorine dioxide contract sterilization. An FDA-registered establishment running validated cycles.
We test
Boulder BioLabs
Microbiology and biological testing — sterility, bioburden, method suitability, LAL/endotoxin, and EO/CD residuals.
We validate packaging
Boulder Package Testing
Sterile barrier and distribution package validation to ISO 11607, ASTM, and ISTA standards.
Parent & hub
Boulder BioMed
The parent company and authority hub tying the family together under one quality system.
One Connected Program
Because regulatory, quality, engineering, sterilization, and testing all live under one roof and one quality system, your submission, your QMS, and your test data are built as one connected program — not stitched together across vendors who have never met.
Request a Consult