The Single-Source Solution
Helping Life Science Companies Bring Products to Market

Engineering, Design
and Development

Ethylene Oxide,
Chlorine Dioxide

Regulatory Affairs
and Quality Assurance

Contract
Testing Lab

Explore Our Family of Companies

Engineering, design and development services to speed your product to market

Boulder iQ provides comprehensive services to move your product from concept to manufacturing.

  • Concept development, rapid prototyping
  • Ergonomics design, human factors research and development
  • Design for manufacturing, commercialization
  • Mechanical and electrical engineering
  • Precision assembly and manufacturing
  • Bacterial endotoxin test (LAL)
  • Bioburden testing
  • Sterility testing
  • Method suitability
  • Fast-turn laboratory testing
  • Integrated product development support
  • Production release documentation
  • Verification and validation testing
Visit Boulder iQ

Fast, safe sterilization services to speed your medical device to market

Quick-turn ethylene oxide (EO) and chlorine dioxide (CD) sterilization services for medical devices and in-vitro diagnostic products.

  • Sole contract sterilizer offering both EO and CD technologies
  • World’s largest contract chlorine dioxide sterilizer
  • Only U.S. company to offer the combination of clean room final assembly, packaging, and quick-turn EO and CD sterilization with in-house biological testing
  • Quick-turn service for all batch sizes
  • Expedited service for urgent and immediate-requirement projects
Visit Boulder Sterilization
boulder sterilization, ethlyene oxide

Comprehensive, efficient regulatory affairs and quality assurance services to speed your device to market

Boulder Regulatory Affairs and Quality Assurance provides full regulatory and quality support for medical devices and in-vitro diagnostic products.
  • U.S. and international regulatory support
  • Extensive audit capabilities
  • Complete services with ISO 13485-compliant quality management systems
  • Clinical trial strategy and planning services
Visit Boulder RA/QA

Efficient, accurate, on-site contract distribution and packaging validation

Boulder BioLabs provides efficient, accurate, on-site contract distribution and packaging validation, with products transitioning seamlessly from sterilization to testing.

  • Environmental testing
  • Drop testing
  • Compression testing
  • Vibration testing
  • Impact testing
  • Accelerated aging testing
  • Real-time aging testing
Visit Boulder BioLabs
  • Bacterial endotoxin test (LAL)
  • Bioburden testing
  • Sterility testing
  • Method suitability
  • Fast-turn laboratory testing
  • Integrated product development support
boulder biolabs