The Boulder BioMed Family
Five companies, one campus, one quality system. From design through sterilization and testing — everything your medical device needs under one roof.
The Boulder BioMed family of companies provides integrated services for medical device manufacturers. Located on a single campus in Boulder, Colorado, our five companies share one quality management system (ISO 13485), enabling seamless handoffs between design, manufacturing, sterilization, biological testing, and package validation.
Boulder iQ
Engineering, Design & Contract Manufacturing
Full-service medical device development from concept through commercialization. Design controls, prototyping, verification and validation testing, and low-to-mid volume contract manufacturing — all under one quality system.
Visit Boulder iQ→Boulder Sterilization
EO & Chlorine Dioxide Sterilization
Contract sterilization services using both ethylene oxide (EO) and chlorine dioxide (CD). Boulder Sterilization operates the world's largest contract chlorine dioxide sterilization capacity, providing a validated alternative for EO-sensitive devices.
Visit Boulder Sterilization→Boulder RA/QA
Regulatory & Quality Consulting
Regulatory strategy, 510(k) and CE marking submissions, quality management system development and auditing, and the AuditIQ platform for streamlined compliance management.
Visit Boulder RA/QA→Boulder BioLabs
Biological Testing & Microbiology
Bioburden testing, sterility testing, bacterial endotoxin testing, and environmental monitoring for medical device manufacturers. Co-located with sterilization for integrated testing workflows.
Visit Boulder BioLabs→Boulder Package Testing
Medical Device Package Validation
Contract package testing lab executing ISTA-aligned test methods and ISO 17025-aligned protocols. Distribution simulation, accelerated aging, seal testing, and sterile barrier integrity — co-located with sterilization on the same campus.
Work With the Whole Family
Need more than package testing? Our integrated campus means your device can move from design to manufacturing to sterilization to package validation without leaving Boulder.
Contact Us