Three Reasons Device Companies Choose Boulder BioLabs
Integrated Pipeline
Sterilize and test without shipping. Boulder Sterilization is next door — the only U.S. contract sterilizer offering both EO and chlorine dioxide under one ISO 13485 system. Your samples walk to the lab.
4-Hour Cycle Release
Faster than typical 6-day RMM offerings. Boulder BioLabs supports 4-hour cycle release using rapid-readout biological indicators. For BI-based release programs, devices clear sterility verification within hours of cycle end.
Single Source
One QMS. One relationship. One roof. Boulder BioLabs operates under the Boulder BioMed ISO 13485 quality management system — same system as Boulder Sterilization and Boulder RA/QA.
Microbiology Testing Built for Medical Device Validation and Release
Focused services done well — not a sprawling test catalog.
Sterility Testing
Sterility testing aligned with ISO 11737-2 and USP <71>. Co-located with Boulder Sterilization. 4-hour BI release option.
Learn more →Bioburden Testing
Bioburden testing aligned with ISO 11737-1. Co-located with Boulder Sterilization for faster cycle iteration and routine monitoring.
Learn more →Method Suitability (B/F)
Bacteriostasis and fungistasis (B/F) method suitability aligned with ISO 11737-2 and USP <71>. The prerequisite for defensible sterility testing.
Learn more →LAL / Endotoxin Testing
Bacterial Endotoxin Testing (LAL/BET) aligned with USP <85>. Gel-clot, turbidimetric, and chromogenic methods for cardiovascular, CSF, class II/III devices.
Learn more →EO Residuals Testing
EO, ECH, and EG residuals testing aligned with ISO 10993-7. Headspace and exhaustive extraction. Co-located with Boulder Sterilization.
Learn more →CD Sterilization Residuals
Chlorine dioxide sterilization residuals testing — co-located with Boulder Sterilization, the only U.S. contract CD sterilizer under ISO 13485.
Learn more →Rapid Cycle Release
Rapid-readout biological indicators — cycle efficacy confirmed in 4 hours. Faster than typical 6-day RMM offerings from national labs.
Learn more →Industries We Support
Specialized testing programs for device categories where the regulatory bar is highest.
What Our Clients Say
Anonymized feedback from medical device companies we support. Names changed to protect commercial confidentiality.
We send our products out for EO sterilization and bioburden together, and having it all happen in one place saves us weeks. No shipping samples across the country, no chasing two vendors. BBL gets it done and gets it back.
What I appreciate most is that I can pick up the phone and actually talk to the person running my test. Try doing that at one of the national labs. The BBL team treats a small order like it matters, because to us it does.
We were up against a submission deadline and needed endotoxin results fast. BBL turned them around without the usual song and dance about queue times and rush fees. That kind of responsiveness is hard to find.
The quote came back same day, the samples were tested days later, and the report was clean and easy to read. For routine bioburden and sterility work, that speed is exactly what a small device company needs.
As a startup, every week counts. BBL understands that and works at our pace instead of making us wait in line behind the big accounts. They've become a real partner in getting our product to market.
Accurate results, on time, every time, and people who pick up the phone when I have a question. BBL does what they say they'll do, which is more than I can say for some of the larger labs we've used.
Our Family of Companies
Boulder BioLabs is one of five companies in the Boulder BioMed family.
EO and CD contract sterilization — the only U.S. provider offering both.
bouldersterilization.com →ASTM D4169, ISTA 3A, accelerated aging. Sister site to Boulder BioLabs.
boulderpackagetest.com →Ready to get days back in your validation schedule?
Scope, price, and a realistic turnaround date back within one business day.
Request a Quote